Hangzhou Formed Medical

Document No.: JCQ-T-017-06 Edition: 3/0 Page: 1/23

Devices Co.,Ltd.
CE Technical Document of
Risk Management Report Effective Date: Jan. 15, 2019
Venturi Mask

Company Name Hangzhou Formed Medical Devices Co.,Ltd.

Building 3, No. 292 Gonghe North Road, Xindeng Town, Fuyang District,
Company Address
311404, Hangzhou, PEOPLE′S REPUBLIC OF CHINA.

Product Venturi Mask

Model PA1201, PA1202, PA1203, PA1204, PA1301, PA1302, PA1303, PA1304

Standard EN ISO 14971:2012

All risks associated with the identified hazards have been evaluated.
After appropriate measures to reduce these risks have been taken, the
Result overall level of risk of the product is reduced to the level of as far as
possible with regard to the intended application and use of the
application.

Approved by:

Date Jan. 15, 2019

 Hangzhou Formed Medical
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Devices Co.,Ltd.
CE Technical Document of
Risk Management Report Effective Date: Jan. 15, 2019
Venturi Mask

Risk Management Plan

1 Foreword
This is a report about the risk management of Venturi Mask. This report includes determination of all substantial dangers
and every substantial cause of each danger, also includes estimation of the damage severity of each kind of danger and
the occur probability of dangers. When a certain risk level is unacceptable, some control measure to depress the risk
should be made, meanwhile, rest risk should be estimated after the control measure is taken. Finally, make all rest risk
level be reduced as far as possible.

2 Scope Applied
The Venturi Mask stated in this risk management are mainly consisted of the following parts.

3 Reference applied
3.1 Relevant standards
S/ N Name of document
1 MDD 93/42/EEC under consideration of council directive 2007/47/EC
EN ISO 13485:2016 Medical devices-Quality management systems-Requirements for regulatory
2
purposes
MEDDEV.2.7/1 Rev 4: 2016 CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED
3
BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC
4 MEDDEV 2.12-1 rev 6:2009 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
5 MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies
6 EN ISO 14971:2012 Medical devices-Application of risk management to medical devices
7 EN 1041:2008 Information supplied by the manufacturer of medical devices
EN ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling
8
and information to be supplied -- Part 1: General requirements
EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements
9
for materials, sterile barrier systems and packaging systems
EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation
10
requirements for forming, sealing and assembly processes
EN ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing
11
within a risk management process
EN ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro
12
cytotoxicity
EN ISO 10993-7:2008/Cor 1:2009 Biological evaluation of medical devices -- Part 7: Ethylene oxide
13
sterilization residuals
EN ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and
14
skin sensitization
EN ISO 10993-12:2012 Biological Evaluation of Medical Devices- Part 12:Sample preparation
15
and reference materials
EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General
16
requirements
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical
17
investigation plans
EN ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classification
18
of air cleanliness
19 EN ISO 14644-2:2000 Cleanrooms and associated controlled environments - Part 2: Specifications
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Devices Co.,Ltd.
CE Technical Document of
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Venturi Mask

for testing and monitoring to prove continued compliance with ISO 14644-1
EN ISO 14698-1:2003 Cleanrooms and associated controlled environments - Biocontamination
20
control - Part 1: General principles and methods
EN ISO 14698-2:2003+AC:2006 Cleanrooms and associated controlled environments -
21
Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data

3.2 Reference related to products

R&D, drawings of samples, standards of products, IFU.

3.3 Other information sources

Repairing records, customers’ complaints, accidents records, articles in professional literatures, etc..

3.4 Definition and abbreviation

Danger: Substantial causes of damage or harm that would affect to patients, operators, environment or other persons.
Risk: Happening frequency and severity of a danger
Evaluation: Determinant the degree and the happening frequency of risk, and estimate the acceptable degree of risk
AIARP: Reasonable and feasible reducing zone

4. Products introduction
4.1 Production introduction
The Venturi Mask Made from the raw material of PVC for medical use, have excellent biocompatibility.
The Venturi Mask are devices that are constructed to supply oxygen or other gases to an individual. For single use,
have been used productively and clinically for scores of years. Masks fit snugly over the nose and mouth, and are
equipped with oxygen concentration diluter which allows settings of oxygen concentration, and a tube that
connects the mask to a storage tank where the oxygen is contained. The Venturi Mask is made from PVC, have
excellent biocompatibility, as they are light in weight, they are more comfortable than some other masks,
increasing patient acceptance. Transparent plastic masks also leave the face visible, allowing care providers to
better ascertain patients’ conditions.
The Venturi Mask is provided in sizes from Pediatric to Adult.
The Venturi Mask is non sterile.

4.2 Intended Use

An oxygen mask has an oxygen tubing, connecting oxygen supply, and mask in the other end of the tube, which
delivers oxygen to patients, and allow settings of oxygen concentration. Short term use.
 Hangzhou Formed Medical
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CE Technical Document of
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Venturi Mask

4.3 Product picture

Figure 1 Venturi Mask with 2 diluters

Figure 2 Venturi Mask with 6 diluters

 Hangzhou Formed Medical
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Devices Co.,Ltd.
CE Technical Document of
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Venturi Mask

Figure 3 Product figure

1 - Mask 2 - Clip 3 - Ribbon 4 – Oxygen tube 5 – Oxygen connector
6 - Diluter 7 - Cap 8 – Ring 9 – Adaptor

4.3 Raw material and auxiliary material

Part Name Material

Mask PVC
Clip Aluminium alloy
Ribbon PU fibre
Oxygen tube PVC
Oxygen connector PVC
Diluter ABS
Cap PP
Ring PP
Adaptor PP
 Hangzhou Formed Medical
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CE Technical Document of
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Venturi Mask

4.4 Specification :

REF Product Description

PA1201 Size S, Pediatric mask, with 2 diluters
PA1202 Size M, Pediatric elongated mask, with 2 diluters
PA1203 Size L, Adult mask, with 2 diluters
PA1204 Size XL, Adult elongated mask, with 2 diluters
PA1301 Size S, Pediatric mask, with 6 diluters
PA1302 Size M, Pediatric elongated mask, with 6 diluters
PA1303 Size L, Adult mask, with 6 diluters
PA1304 Size XL, Adult elongated mask, with 6 diluters

4.5 Instructions For Use

1) Choose appropriate diluter for desired oxygen concentration.
2) Insert large end of diluter into corrugated tube connected to mask.
3) If humidification is to be administered, snap humidification hood over diluter.
4) Connect one end of the oxygen tubing to diluter inlet and other end to oxygen source.
5) Adjust O2 flow to level stamped on face of a diluter to assure indicated concentration.
6) Place contoured mask on face. Adjust aluminum bar for comfort fit. Place retaining strap around head slightly
above ear level. Pull strap ends to desired comfort to maintain mask position.

4.6 Caution
1) For single use only. Discard after use.
2) Do not use if the package open or damaged.
3) Do not store at extreme temperature or humidity. Store in cool and dry place.
4) Ensure that all connections are secure and air circulates freely through the tubing.

4.7 Contraindications
1) This device can’t be used for the patients with facial trauma and PVC allergy.
2) The product is forbidden for use if the individual package is damaged
3) Repeat use is forbidden.

5. General principle of risk acceptance

5.1 Evaluation principle of severity
No. Grade Severity
1 Negligible No harm or little probability of causing harm
2 Minor May be minor damage
3 Serious May be die or severely harmed
4 Critical May be many people die or severely harmed
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CE Technical Document of
Risk Management Report Effective Date: Jan. 15, 2019
Venturi Mask

Cross infection

5.2 Evaluation principle of damage happening frequency

No. Grade Probability

1 Improbable < 10 −6
2 Remote < 10 −5 and ≥10 −6
3 Occasional < 10 −4 and ≥10 −5
4 Probable < 10 −3 and ≥10 −4

5.3 Evaluation principle of risk

Risk=Severity × Happening Frequency
Happening Severity
Frequency 1: Negligible 2: Minor 3: Serious 4: Critical
4: Probable NACC NACC NACC NACC
3: Occasional ACC ACC NACC NACC
2: Remote ACC ACC ACC NACC
1: Improbable ACC ACC ACC ACC
NACC = unacceptable
ACC = acceptable

6. Actualization of risk management process

6.1 Methods
Risk analysis of Venturi Mask runs through the whole lifecycle of the products. Primary risk analysis begins in
scheming products, brings forward measures to debase or reduce risk, validates the primary measures in process
of product R&D, analyzes whether there exists new danger, present severity and happening frequency of danger,
and revises when necessary. Audit all risk after developing and exploiting products to ensure all risk are reduced
to the level of as far as possible. If there is any feedback on safety, the risk analysis should be validated again and
amendment should be made necessarily.

Risk analysis team is consisted of:

Reviewers Department Position Responsibilities

From R&D and a product technical point of view to
Mr. Guo Yongxuan R&D Department Supervisor
determine the possible defects
From the quality inspection point of view to
Ms. Du Queye Quality Department QA director
determine the possible defects
From the productive process point of view to
Mr. Bai Yingchun Product Department Manager
determine the possible defects
From the sales process point of view to determine
Ms. Gao Jun Sales Department Manager
the possible defects
From the medical point of view to estimate
Dr. Huang Fengping Huashan Hospital Vice president
damage.

7. Verification
The first verification is that make sure that the risk control measure has been implemented in the final design.
The second verification is that ensure that the measure as implemented actually reduces the risk.
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CE Technical Document of
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Venturi Mask

8. Method(s) of obtaining relevant post-production information

Manufacturers should establish generic procedures to collect information from various sources such as users,
service personnel, training personnel, incident reports and customer feedback.
This information shall be evaluated for possible relevance to safety, especially the following:
1. If previously unrecognised hazards or hazardous situations are present or
2. If the estimated risk(s) arising from a hazardous situation is/are no longer acceptable.
If any of the above conditions occur:
1) the impact on previously implemented risk management activities shall be evaluated and shall be feedback as
an input to the risk management process and
2) a review of the risk management file for the medical device shall be conducted; if there is a potential that the
residual risk(s) or its acceptability has changed, the impact on previously implemented risk control measures shall
be evaluated.

9.Risk management procedure

The risk management procedure contains the following process: risk analysis, risk evaluation, risk control, overall
residual risk evaluation, risk management report, production and post-production and etc.
The risk management procedure is in accordance with as annex B of EN ISO 14971:2012
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CE Technical Document of
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Venturi Mask
 Hangzhou Formed Medical
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CE Technical Document of
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Venturi Mask

Risk Analysis Report

1. Risk Analysis
Identification of qualitative and quantitative characteristics:(acc. to EN ISO 14971:2012, Annex C)
Question Characteristics Hazard
Question Possible Risks
No Determination Identification
H5.1
An oxygen mask has an oxygen H5.2
tubing, connecting oxygen H5.3
supply, and mask in the other H5.4
Hazards related to
end of the tube, which delivers H5.5
What is the intended use and how is the use of the device
C.2.1 oxygen to patients, and allow H5.7
the medical device to used? and contributory
settings of oxygen H5.8
factors
concentration. Short term use. H5.9
This product is used by the H5.10
Medical staff following IFU. H5.11
H5.12
Is the medical device intended to
C.2.2 No.
be implanted?
Is the medical device intended to
C.2.3 be in contact with the patient or No.
other persons?
What materials or components
are utilized in the medical device Main Material is Medical H2.2
C.2.4 Biological hazards
or are used with, or are in contact PVC. H2.5
with, the medical device?
Is energy delivered to or
C.2.5 No.
extracted from the patient?
Are substances delivered to or
C.2.6 No.
extracted from the patient?
Are biological materials
processed by the medical device
C.2.7 No.
for subsequent re-use,
transfusion or transplantation?
Is the medical device supplied
sterile or intended to be sterilized
C.2.8 by the user, or are other No.
microbiological controls
applicable?
Is the medical device intended to
C.2.9 be routinely cleaned and No.
disinfected by the user?
Is the medical device intended to
C.2.10 No.
modify the patient environment?
Are measurements taken?
Factors that should be considered
include the variables measured
C.2.11 No.
and the accuracy and the
precision of the measurement
results.
C.2.12 Is the medical device No.
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interpretative?
Is the medical device intended for
use in conjunction with other
C.2.13 No.
medical devices medicines or
other medical technologies?
Are there unwanted outputs of
C.2.14 No.
energy or substances?
Yes, Rough handling during Biological hazards H2.3
transportation may cause
Environmental
breakage of outer garment
hazards and H3.7
and breakage of small
contributory factors
package. And the raw
Is the medical device susceptible
C.2.15 materials of the product are
to environmental influences?
macromolecular materials, Hazards arising from H7.4
the packaging materials are functional failure,
PE bag, the temperature and maintenance and
humidity are required ageing H7.9
during storage.
Environmental
Does the medical device Yes, Used product will
C.2.16 hazards and H3.13
influence the environment? cause environment pollution
contributory factors
Are there essential consumables
C.2.17 or accessories with the medical No.
device?
Is maintenance or calibration
C.2.18 No.
necessary?
Does the medical device contain
C.2.19 No.
software?
Hazards related to
the use of the device
H5.9
and contributory
Does the medical device have a Yes, The aging test report factors
C.2.20
restricted shelf-life? support 5 years shelf-life Hazards arising from
functional failure,
H7.9
maintenance and
ageing
Are there any delayed or
C.2.21 No.
long-term use effects?
To what mechanical forces will
C.2.22 No.
the medical device be subjected?
Yes, Product materials, Biological hazards H2.3
packaging materials and Hazards arising from H7.4
What determines the lifetime of
C.2.23 sealing properties functional failure,
the medical device?
determine the life of the maintenance and H7.9
product ageing
Hazards related to
Is the medical device intended for the use of the device
C.2.24 Yes, it is for single use H5.10
single use? and contributory
factors
Hazards related to
Is safe decommissioning or Disinfect and destroy by
the use of the device
C.2.25 disposal of the medical device medicinal organization after H5.10
and contributory
necessary? use
factors
C.2.26 Does installation or use of the Yes, the product must be Hazards related to H5.7
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medical device require special used by trained medical the use of the device
training or special skills? professionals and contributory
factors
H5.1
H5.2
H5.3
H5.4
Yes, refer to user manual or Hazards related to
H5.5
How will information for safe use device label. Use the device the use of the device
C.2.27 H5.7
be provided? by the skilled/trained and contributory
H5.8
personnel. factors
H5.9
H5.10
H5.11
H5.12
Will new manufacturing
C.2.28 processes need to be established No.
or introduced?
Is successful application of the
medical device critically
C.2.29 No.
dependent on human factors
such as the user interface?
Can the user interface design
C.2.29.1 No.
features contribute to use error?
Is the medical device used in an
C.2.29.2 environment where distractions No.
can cause use error?
Does the medical device have
C.2.29.3 No.
connecting parts or accessories?
Does the medical device have a
C.2.29.4 No
control interface?
Does the medical device display
C.2.29.5 No
information?
Is the medical device controlled
C.2.29.6 No
by a menu?
H5.1
H5.2
H5.3
It is used for medical H5.4
Hazards related to
personnel to implement H5.5
Will the medical device be used the use of the device
C.2.29.7 peripheral vascular H5.7
by persons with special needs? and contributory
interventional diagnosis and H5.8
factors
treatment for patients. H5.9
H5.10
H5.11
H5.12
Can the user interface be used to
C.2.29.8 No.
initiate user actions?
Does the medical device use an
C.2.30 No.
alarm system?
In what way(s) might the medical
C.2.31 No.
device be deliberately misused?
Does the medical device hold
C.2.32 No.
data critical to patient care?
C.2.33 Is the medical device intended to No.
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be mobile or portable?
H7.7
Yes, the essential Hazards arising from
Does the use of the medical H7.8
performance determine the functional failure,
C.2.34 device depend on essential H7.9
safety and effectiveness of maintenance and
performance? H7.10
the product ageing
H7.11
If components of the medical
device are securely mounted for
C.2.35 No.
the expected service lifetime of
the medical device?
What multi-purpose outputs (e.g.
low-intensity and high-intensity)
C.2.36 No.
for different treatments are
provided for the medical device?
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Annex B: The details of implementation of risk control measure(s)

No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
1. Energy Hazards
H1.1 Electricity No
H1.2 Heat No
H1.3 Mechanical force No
H1.4 Lonizing radiation No
H1.5 Non-ionizing No
radiation
H1.6 Electromagnetic No
fields
H1.7 Moving parts No
H1.8 Suspended masses No
H1.9 Patient support No
device failure
H1.10 Pressure (vessel No
rupture)
H1.11 Acoustic pressure No
H1.12 Vibration No
H1.13 Magnetic No
fields(e.g.MRI)
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No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
2. Biological hazards
H2.1 Bio-contamination Don’t produce in the clean room 3 2 6 Produce the product in the clean room Clean room validation 3 1 3 Y Y
to cause product polluted with report
microbes, Causing patient’s
infection
H2.2 Bio-incompatibility The material itself contains 3 2 6 1.Make the key raw material and Biocompatibility test 3 1 3 Y Y
Endotoxin, A certain amount purchased parts standards, raw materials report
of Endotoxin come into the and purchased parts should meet the
human body and harm patient. medical requirements
The material itself leads to 2.Final product pass Biocompatibility test
hemolytic reaction or it is 3.Strictly implement the procurement
toxicity, and harm patient. control procedures
H2.3 Bio-incompatibility Single package sealing failure, 3 2 6 1.Product packing shall be strictly carried product package 3 1 3 Y Y
the product was contaminated by out in accordance with the single package validation report
bacteria, Causing patient’s operating procedures.
infection 2.Make validation on product package.
H2.4 Bio-incompatibility No
H2.5 Toxicity The chemical composition of the 3 2 6 1.Make the key raw material and Biocompatibility test 3 1 3 Y Y
material is toxic, A certain purchased parts standards, raw materials report
amount of toxic substance enters and purchased parts should meet the
the veins of the human body and medical requirements
harm user 2.Final product pass Biocompatibility test
3.Strictly implement the procurement
control procedures
H2.6 Mutagenicity No
H2.7 Oncogenicity No
H2.8 Teratogenicity No
H2.9 Carcinogenicity No
H2.10 Re-and/or No
cross-infection
H2.11 Inability to No
maintain hygienic
safety
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No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
H2.12 Degradation No
H2.13 Incorrect No
formulation(chemical
composition)
3. Environmental hazards and contributory factors
H3.1 Electromagnetic fields No
H3.2 Inadequate supply of No
power or coolant
H3.3 Susceptibility to No
electromagnetic
interference
H3.4 Emissions of No
electromagnetic
interference
H3.5 Inadequate supply of No
power
H3.6 Inadequate supply of No
coolant
H3.7 Storage or operation The storage environment 2 2 4 It is declared the storage condition in the User Manual 2 1 2 Y Y
outside prescribed will cause product failure User Manual
environmental
conditions
H3.8 Incompatibility with No
other devices
H3.9 Accidental mechanical No
damage
H3.10 Contamination due to No
waste products and/or
device disposal
H3.11 Under least favorable No
working condition
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No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
H3.12 Mechanical strength No
and resistance to
heat
H3.13 Environment Used product will cause 2 2 4 It is declared the product after use is User Manual 2 1 2 Y Y
pollution environment pollution processed according to the medical waste
management regulation
4.Hazards resulting from incorrect output of energy and substances
H4.1 Electricity No
H4.2 Radiation No
H4.3 olume No
H4.4 Pressure No
H4.5 Supply of medical No
gases
H4.6 Supply of Oxygen No
agents
5. Hazards related to the use of the device and contributory factors
H5.1 Inadequate labeling Inadequate labeling will cause 2 2 4 It is declared the usage in the User User Manual 2 1 2 Y Y
incorrect use. Manual.
H5.2 Inadequate Inadequate operating will cause 2 2 4 Usage and attention of using are User Manual 2 1 2 Y Y
operating the medical device cannot elaborated 1n the User Manual.
Instructions achieve its intended use.
H5.3 Inadequate Inadequate Specification of 2 2 4 The detailed Specification of User Manual 2 1 2 Y Y
Specification of accessories will cause the accessories are elaborated 1n the User
accessories equipped monitor device Manual.
are not match, and the medical
device cannot achieve its
intended use.
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No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
H5.4 Inadequate The product is damaged and is 2 2 4 Check the product before use and User Manual 2 1 2 Y Y
Specification of not checked, and the product can attentions are elaborated 1n the User
Pre-use checks not be used. Manual.
Error information or inadequate
information of attentions will
cause misusing.
H5.5 Overcomplicated Overcomplicated operating 2 2 4 Instructions for use in User Manual are User Manual 2 1 2 Y Y
Operating Instructions, Product is used simple and easy to understand.
instructions incorrectly
H5.6 Inadequate No
specification of
service and
maintenance
H5.7 Use by will cause the medical device 2 2 4 The warning for the device must be used User Manual 2 1 2 Y Y
unskilled/untrained cannot achieve its intended use. by the medical professionals.
personnel or harm the user and the patient.
H5.8 Reasonably Used wrongly for 2 2 4 contraindications are elaborated in the User Manual 2 1 2 Y Y
Foreseeable misuse contraindications and harm the User Manual.
user and the patient.
H5.9 Insufficient warning Used wrongly and used the 2 2 4 warnings are elaborated in the User User Manual 2 1 2 Y Y
of side effects and product beyond the date of Manual.
cannot use expiry harm the user and the
beyond the date of e patient.
xpiry
H5.10 Inadequate warning Failing to destroy the product 2 2 4 The warning of only single use are User Manual 2 1 2 Y Y
of hazards likely after use and be re-used, harm elaborated in the User Manual and label Label
with re-use of single the user and the patient.
use devices.
H5.11 Incorrect Inaccuracy of guiding and 2 2 4 Make the product process inspection and Product process 2 1 2 Y Y
measurement and positioning catheter harm the the final product quality standard inspection Final product
other metrological patient. quality standard
aspects.
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No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
H5.12 Incompatibility with will cause the product 2 2 4 Make the product physical structure Product structure 2 1 2 Y Y
consumables/accessories/o not match with the design and the final product quality drawing
ther devices monitor device its standard Final product quality
intended use. standard
H5.13 Sharp edges or points No
6. Inappropriate, inadequate or over-complicated user interface (man/machine communication)
H6.1 Mistakes and judgement No ..
errors
H6.2 Lapses and cognitive No
recall errors
H6.3 Slips and blunders (mental No
or physical)
H6.4 Violation or abbreviation No
of instructions,
procedures, etc.
H6.5 Complex or confusing No
control system
H6.6 Ambiguous or unclear No
device state
H6.7 Ambiguous or unclear No
presentation of settings,
measurements or other
information
H6.8 Mispresentation of results No
H6.9 Insufficient visibility, No
audibility or tactility
H6.10 Poor mapping of controls No
to action, or of displayed
information to actual state.
H6.11 Controversial modes No
Or mappings as compared
to existing equipment.
 Hangzhou Formed Medical
Document No.: JCQ-T-017-06 Edition: 3/0 Page: 20/23
Devices Co.,Ltd.
CE Technical Document of
Risk Management Report Effective Date: Jan. 15, 2019
Venturi Mask

No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
7. Hazards arising from functional failure, maintenance and ageing
H7.1 Erroneous data transfer. No
H7.2 Lack of, or inadequate No
specification for
maintenance including
inadequate specification of
post maintenance functional
checks
H7.3 Inadequate No
maintenance
H7.4 Inadequate packaging It may cause the medical 3 2 6 Select Suitable package materials and Package validation 3 1 3 Y Y
(contamination and/or device damage, cannot package forms, Make the package report
deterioration of the device) achieve its intended use. validation to make sure the packing is
effective.
H7.5 Re-use and/or Improper No
re-use
H7.6 Deterioration in function No
(e.g. gradual occlusion of
fluid/gas path, or change in
resistance to flow,
electrical conductivity) as
a result of repeated use.
H7.7 Poor sealing property of It may cause mask 2 2 4 Determine the final product quality Final product quality 2 1 2 Y Y
mask leakage standard, and make final product standard
performance test Bench Test report
H7.8 There are foreign objects in It may cause mask 2 2 4 Determine the final product quality Final product quality 2 1 2 Y Y
the mask broken standard, and make final product standard
performance test Bench Test report
H7.9 The product is aging It may cause product 2 2 4 Determine the raw material quality Raw material quality 2 1 2 Y Y
performance failure standard, make the shelf life verification standard
and clarify the product shelf life in IFU Shelf life verification
and label protocol and report
IFU and label
 Hangzhou Formed Medical
Document No.: JCQ-T-017-06 Edition: 3/0 Page: 21/23
Devices Co.,Ltd.
CE Technical Document of
Risk Management Report Effective Date: Jan. 15, 2019
Venturi Mask

No. Hazard Risk Risk Reduction Measure Evidence Risk Evaluation V/E NH ALOR
Evaluation After Adopting
The Measure
General Identify hazards S O RL S O RL
H7.10 The product component is It may cause leakage 2 2 4 Determine the final product quality Final product quality 2 1 2 Y Y
not securely connected and product standard, and make final product standard
performance failure performance test Bench Test report
H7.11 Poor surface of mask It may cause hurt of 2 2 4 Determine the final product quality Final product quality 2 1 2 Y Y
patient’s face standard, and make final product standard
performance test Bench Test report
 Hangzhou Formed Medical
Document No.: JCQ-T-017-06 Edition: 3/0 Page: 22/23
Devices Co.,Ltd.
CE Technical Document of
Risk Management Report Effective Date: Jan. 15, 2019
Venturi Mask

2.Risk control option analysis

After risk reduction measures are taken, the risk has been reduced as far as possible, No new risk has been caused
after the measures are taken while the process of reducing risk is as far as possible. Risk evaluation and control shall
be re-performed in case of the change in selection and design of production process and material.

3.Risk/benefit analysis
The risk(s) from all identified hazards have been evaluated. The results of this assessment have been recorded in
the risk management file .The benefit from the product is greater than it’s risk of hazard.

4.Overall remaining risk evaluation

Remaining risk RL<4 neglectable remaining risk
1-15: neglectable remaining risk, no further actions;
The number of Remaining risk RL≥4 16-30: remaining risk, acceptable;
>30: remaining risk is usually not acceptable

The number of remaining risk RL≥4 :11

Conclusion
The overall remaining risks are Acceptable.

5.Post-production experience
Since this production has gone into production, the sales department research the information which feeds back
from the customers, the customers assured the instrument quality stability and the security, below has not the
situation:

5.1 Has not the situation which beforehand the cognition harm has not appeared.
5.2 Has not situation that estimated one or more risk made by harm is accepted.
5.3 Initial evaluates has not expired.

6.Review of risk management experience

To reduced these risks before taking some appropriate measure, all applied project and using this project regarding
this instrument, each kind of risk lever all can accept; After taking the risk controlling measure, all leaves behind the
surplus risk also can be accepted.
 Hangzhou Formed Medical
Document No.: JCQ-T-017-06 Edition: 3/0 Page: 23/23
Devices Co.,Ltd.
CE Technical Document of
Risk Management Report Effective Date: Jan. 15, 2019
Venturi Mask

7.Conclusion
Show as the risk control, all of the potential risk are reduce to the level of as far as possible.
The risk management plan has been appropriately implemented.
Because of adopt the above measures, it great reduce the rate of all kinds of harms happening and make them to
the level of ALARP.

Abbreviations used：

RE Risk Evaluation
S Severity
O Occurrence
RL Risk Level = Severity × Occurrence × Detection
RRM Risk Reduction Measure
V Verified person
E Effectiveness
Acc Accept
New hazard generated (no/yes - if yes, then number of new hazard
NH
indicated)
ALOR Acceptable Level of Risk