Minimally Invasive Therapies Group System Risk Management

PB500 Series Product Risk Assessment / Risk Analysis Chart - General Information

Document #: 10037183 Revision: W

1 Purpose and Scope

The purpose of this analysis is to identify hazards associated with the intended use, as well as, reasonably foreseeable misuse of the medical device and any
potentially resulting harms in accordance with EN ISO 14971.

This document covers the patient, all intended users, and the device itself during manufacture, use, servicing, transportation, and storage of the medical device.

2 Assumptions:
This hazard analysis assumes that the PB560, PB540, PB520 and PowerPack shall only be operated by qualified, properly trained personnel (i.e. used by prescription
only). The users of thePB560, PB540, PB520 and PowerPack include: clinicians, physicians, nurses, homecare providers, patients and patient’s families.

Per the Risk Management Plan, 10035479, risk management activities are retrospective to comply with EN ISO 14971:2012, and Remediation Plan for Risk
Management Documents 10130032, and shall be carried out in accordance with MITG Risk Management Method GS10004411. Because this is retrospective, the
columns in the Product Risk Analysis table below that call for the 'Pre-mitigation risk assessment' will not be populated. The 'Post mitigation' (risidual) risk assessment
columns will be the only ones used because the mitigations have already been applied. The PB500 Risk Assessment Team considered the probability of both P1 and
P2 occurring together without defining each other separately. The residual probability of harm was arrived by combining engineering design expertise with data from a
3 years period of PB500 customer complaints.

Within this file cells that have been shaded brown represent the start of the hazard. All causes, harms and mitigations listed below this line are appropriate for the
hazard. P1, P2 and risk zones are correct for the row associated with the 'harm x severity' found on the same row.

Grey shading has been used to block out unused cells and are considered equivalent to 'not applicable' for documentation purposes.

3 Intended Users and Use Environment

Intended Users
The ventilator is aand Use·        
Environment:
restricted Risk Management
medical activities
device intended forare
useretrospective totrained
by qualified, comply personnel
with EN ISOunder
14971:2012 [R5] andofRemediation
the direction Plan
a doctor and forbe
may Riskoperated
Management
by Documents 10130032 [R10], and shall be carried out in accordance with MITG Risk Management Metho
clinicians, physicians, nurses, homecare providers, patients and patient’s families.

3.2 The intended use environments for the above personnel include:

The PB500 ventilator is intended for use in institutional, home, and portable settings. The ventilator is not for use as an emergency transport ventilator.

3.3 Intended Patient Population:

The PB500 series ventilators are indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 11 lbs (5 kg)
who require mechanical ventilation delivered invasively or non-invasively.

4 System Definition/Exclusions:
N/A

5 Characteristics Related to Safety

5.1 Primary Operating Function(s):
The PB500 ventilators are applicable for adult and pediatric patients who require the following general types of invasive (via
5.2 endotracheal and tracheostomy
Frequently Used Function(s): tubes) or non-invasive (via mouthpiece, nasal mask or full face mask) ventilatory support, as
prescribed by an attending doctor:
N/A
• Positive Pressure ventilation
• Assist/Control, SIMV, or CPAP modes of ventilation
GS10004411, Attachment D • Breath types including Volume Control, Pressure Control, and Pressure Support Revision 202 Page 1 of 14
10037183 Rev W

PB560 also supports volume control ventilation

 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - General Information

5.3 Essential Performance:

Essential Performance for the PB560 ventilator is defined within RE00147193.

6 Standard Revisions:
The standards referenced in the Risk Anaysis Chart correspond with the following standard revisions:
Medical Electrical Equipment - Part 1: General Requirements for Safety - Collateral Standard - Safety Requirements for Medical
EN 60601-1:2006 + A12:2014 Electrical Systems
EN ISO 10993-1:2009 Biological Evaluation of medical devices Part 1: Evaluation and testing within a risk management process

Lung Ventilators for Medical Use- Particular Requirements for Basic Safety and Essential Performance Part 2: Home Care
EN 10651-2:2009 Ventilators for Ventilator-Dependent Patient

IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard:
IEC 60601-1-11:2015 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EN 60601-1-6:2010 + A1:2014
IEC 60601-1-6: 2010 +A1:2013 Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral standard: Usability
EN 60601-1-8:2007 + A11:2017
IEC 60601-1-8:2006 + A1:2012 General
Medical Requirements, tests and
electrical equipment Partguidance for alarm
2-55: Particular systems in medical
requirements for basicelectrical
safety andequipment
essentialand medical electrical
performance systems
of respiratory gas
EN ISO 80601-2-55:2011 monitor
Medical Electrical Equipment - Part 2-72:Particular requirements for basic safety and essential performance of home healthcare
EN ISO 80601-2-72:2015 environments ventilator-dependent patients

EN 60601-1-2:2015 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:
IEC 60601-1-2:2014 Electromagnetic Disturbances - requirements and tests

7 PB560 Worst case Testing

Rationale for Worst Case Tubing:
The characteristics of the patient circuit impact ventilator’s performance in multiple ways by dynamic interaction with the ventilator’s pneumatic system as well as
through thermodynamic and fluid mechanic phenomena pursuant to varying patterns and dynamic characteristics of gas flow through the patient-ventilator system. The
accuracy of the measurement of timing and magnitude of pressure and flow changes for detection are dependent on tubing characteristics. The accuracy for delivered
and exhaled tidal volumes are directly related to the respective accuracy of the tubing compliance volume during inhalation and exhalation. The ratio of tubing
compliance to the patient’s respiratory compliance as well as the rate of circuit pressurization (function of flow rate and circuit resistance) are among the main factors
influencing the accuracy of tubing compliance volume. Therefore, the worst-case patient circuit for volume-based ventilation is considered to be the one with highest
resistance and the highest compliance.
In general, higher circuit resistance poses more challenges for pressure-based ventilation. For testing, the worst-case patient circuit will be selected from amongst the
specified breathing circuits based on their compliance and resistance properties. Therefore, the worst-case patient circuit for verification is considered to be the one
with highest resistance and the highest compliance i.e. P/N: 5094000 and 5093900.

Rationale for Bacteria Filters (As per RE00164878):

351U5856 Bacteria Filters are considered least favorable due to highest resistance and volume combination of all standard bacteria filters recommended for use with
the PB560.

GS10004411, Attachment D
10037183 Rev W Revision 202 Page 2 of 14
 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Document #: 10037183 Revision: W

Reference
ISO 14971

Response Potential
Question Factors to Consider Potential Hazards(s) Notes / Comments
(N/A = Not Relevant) Hazardous situation(s)

What is the intended use and how What is the medical device's role The Puritan Bennett™ 560 Ventilator is Refer to RE00076775 N/A N/A
is the medical device to be used? relative to: indicated for the continuous or Ventilation Hazards
• diagnosis, prevention, intermittent mechanical
monitoring, treatment, or ventilatory support of patients weighing
alleviation of disease, at least 11 lb (5 kg) who require
mechanical ventilation.
The ventilator is a restricted medical
• compensation for injury or
device intended for use by qualified,
handicap or
trained personnel under the direction of
a doctor.

Specifically, the ventilator is applicable

for adult and pediatric patients who
• replacement or modification of require the following general types of
anatomy, or control of invasive or non-invasive ventilatory
conception? support, as prescribed by an attending
doctor:
• Positive Pressure ventilation
• Assist/Control, SIMV, or CPAP modes
C.2.1

of ventilation
• what are the indications for use
• Breath types including Volume Control,
(e.g., patient population)?
Pressure Control, and Pressure Support

The ventilator may be operated by:

• Respiratory therapists
• Doctors
Does the medical device sustain • Nurses
or support life? • Homecare providers
• Patient and patient’s families

Is special intervention necessary

in the case of failure of the
medical device?

Is the medical device intended to Consider: the location of N/A Refer to RE00076775 N/A N/A
be implanted? implantation, the characteristics Ventilation Hazards
of the patient population, age,
weight, physical activity, the
C.2.2

effect of aging on implant

performance, the expected
lifetime of the implant, the
reversibility of the implantation.

GS10004411, Attachment D
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 Ventilation Hazards

Minimally Invasive Therapies Group System Risk Management

PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Is the medical device intended to Nature of the intended contact, N/A N/A N/A
be in contact with the patient or i.e. surface contact,
other persons? invasive contact, or implantation None of the parts of the ventilator is in
and, for each, the period and direct patient contact. A breathing circuit
frequency of contact. is connected to the ventilator. The
• surface contact points; breathing circuit does not come into
• invasive contact / contact contact with the patient directly. The
C.2.3

through body orifices; ventilator may be used with an

• implantable contact endotracheal tube, tracheal tube, face
(permanent / absorbable) mask, nasal mask or prongs, or
mouthpiece.

What materials or components Consider: Clinicians may use a variety of N/A N/A
are utilized in the medical device • compatibility with relevant interfaces to connect patients to the
or are used with, or are in contact substances; ventilator: nasal masks or full face
with, the medical device? • compatibility with tissues or masks; endotracheal or tracheotomy
body fluids; tubes.
• whether characteristics relevant
to safety are known;
• is the device manufactured
utilizing materials of animal
C.2.4

origin? See Annex I and ISO

22442 Annex I – Biological
Hazards ISO 22442-1:2007 =
provides requirements and
guidance on risk management
related to the hazards typical of
medical devices manufactured
utilizing animal tissues or
derivatives

Is energy delivered to or Consider: N/A N/A N/A N/A

extracted from the patient? • the type of energy transferred;
• its control, quality, quantity,
C.2.5

intensity, and duration;

• whether energy levels are higher
than those currently used for similar
devices.

Are substances delivered to or Consider: The ventilator delivers regulated air and/or
Refer to RE00076775 Ventilation Hazards N/A N/A
extracted from the patient? • whether the substance is delivered oxygen to the patient via a medical pipeline
or extracted; system or from gas cylinders. It is supplied
to the patient circuit through check valves
• whether it is a single substance or and exits to the patient circuit close to
range of substances; patient pressure.
C.2.6

• the maximum and minimum transfer This ventilator is not for use with anesthetic
rates and control thereof.
gases.

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 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Are biological materials Consider: N/A N/A N/A N/A

processed by the medical device the type of process and substance(s)
processed (e.g., auto-transfusion,
C.2.7

for subsequent re-use,

dialysis, blood component, or cell
transfusion, or transplantation? therapy processing).

Is the medical device supplied Consider: N/A N/A N/A N/A

sterile or intended to be sterilized • whether the medical device is
by the user, or are other intended for single use or to be The ventilator is not a sterile device
reusable;
microbiological controls
applicable?
• any packaging;
• shelf-life issues;
• limitation on the number of re-use
cycles;
• method of product sterilization;
• the impact of other sterilization
methods not intended by the
manufacturer.
• Is the medical device properly
C.2.8

marked to inform the user whether it

is for single use or to be re-used?
• Does the packaging clearly indicate
any limitation of handling or shelf-life?

• Does the accompanying document

clearly indicate proper methods of and
agents to be used for cleaning or
sterilization, and inform about
frequencies of cleaning?

• Simplicity of disassembling /
reassembling and any USE errors
connected to these?

Is the medical device intended to Consider: All external panels and surfaces should be Refer to RE00076775 N/A N/A
be routinely cleaned and • the types of cleaning or disinfecting cleaned before and after each patient use Ventilation Hazards
disinfected by the user? agents to be used and any limitations and as often as necessary to keep the
on the number of cleaning cycles. ventilator clean. Additionally the ventilator
should be cleaned the ventilator
periodically, whenever it is soiled or dirty,
before any maintenance operation, and
before storing the ventilator.
Approved Cleaning Solutions for Exterior
Ventilator Surfaces:
Mild dishwashing detergent
C.2.9

70% isopropyl alcohol (rubbing alcohol)

10% chlorine bleach (90% tap water)
Glutaraldehyde
• The design of the medical device can Hospital disinfectant cleaners
influence the effectiveness of routine Hydrogen peroxide
cleaning and disinfection. In addition, 15% ammonia (85% tap water)
consideration should be given to the Ammonia-based household cleaners
effect of cleaning and disinfecting Household cleaners
agents on the safety or performance of
the device. Instruction for the cleaning of the
accessories is to follow the manufacturer’s
instructions for cleaning the ventilator’s
accessories and components, including the
patient circuit.
GS10004411, Attachment D
10037183 Rev W Revision 202 Page 5 of 14
The exhalation block is intended for single
use by a single patient . It may periodically
 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Is the medical device intended to Consider: The ventilator modifies the patient's Refer to RE00076775 N/A N/A
modify the patient environment? • temperature; breathing environment. User-selectable Ventilation Hazards
• humidity; ventilation modes are:
• atmospheric gas composition; • Assisted Controlled Volume (V A/C)
• pressure; • Assisted Controlled Pressure (P A/C)
• light. • Volume Synchronized Intermittent
Mandatory Ventilation (V SIMV)
• Pressure Synchronized Intermittent
C.2.10

Mandatory Ventilation (P SIMV)

• Continuous Positive Airway Pressure
(CPAP)
• Pressure Support Ventilation with apnea
ventilation (PSV/ST)

Are measurements taken? Consider: The ventilator measures and monitors

the variables measured and the patient respiratory parameters. A trained
accuracy and the precision of the user will need to understand, evaluate and
measurement results. adjust parameters.
Also, users have to be aware of
frequencies at which measurements
have to be initiated, parameters
influencing the result, consumables
C.2.11

needed, how to handle or interpret

the results. Standard issues are
legibility and exactness of displays.
Neglecting routine maintenance also
might cause wrong results.

Is the medical device Consider:

interpretative? whether conclusions are presented by
the medical device from input or
acquired data, the algorithms used,
and confidence limits. Special
C.2.12

attention should be given to

unintended applications of the data or
algorithm.

Is the medical device intended for Consider: identifying any other

use in conjunction with other medical devices, medicines, or other
medical devices, medicines, or medical technologies that can be
involved and the potential problems
C.2.13

other medical technologies? associated with such interactions, as

well as patient compliance with the
therapy.

Are there unwanted outputs of • Energy-related Consider: noise and There are no unwanted outputs of energy Refer to RE00076775 N/A N/A
energy or substances? vibration, heat, radiation (including or substances under normal operating Ventilation Hazards
ionizing, non-ionizing, and conditions.
ultraviolet /visible/infrared radiation),
contact temperatures, leakage
currents, and electric or magnetic
fields.
C.2.14

GS10004411, Attachment D
10037183 Rev W Revision 202 Page 6 of 14
 Are there unwanted outputs of There are no unwanted outputs of energy Refer to RE00076775 N/A N/A
energy or substances? Minimally
or substances Invasive
under normal operatingTherapies Group
Ventilation System Risk Management
Hazards
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions
conditions.

• The adverse effects of noise,

vibration, heat, and waste products
(exhaust gases) on physiology and
C.2.14

psychology of users and thirds.

• Substance-related Consider:
substances used in manufacturing,
cleaning or testing having unwanted
physiological effects if they remain in
the product.

• Other substance-related Consider:

discharge of chemicals, waste
products, and body fluids.

Is the medical device susceptible Consider: the operational, transport Yes – temperature, pressure, humidity, Refer to RE00076775
to environmental influences? and storage environments. These vibration, electrical/magnetic field. Ventilation Hazards
include light, temperature, humidity,
vibrations, spillage, susceptibility to
C.2.15

variations in power and cooling

supplies, and electromagnetic
interference.

Does the medical device Consider:: Yes – alarm noises/notifications. Refer to RE00076775 N/A N/A
influence the environment? • the effects on power and cooling Ventilation Hazards
supplies;
C.2.16

• emission of toxic materials;

• the generation of electromagnetic
disturbance

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 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Are there essential consumables Consider: specifications for such Consumables and Replacement Intervals Refer to RE00076775 N/A N/A
or accessories associated with consumables or accessories and any Ventilation Hazards
the medical device? restrictions placed upon users in their • Air Inlet Filter - (Foam + Fine Particle)
selection of these. Once a month or more often, depending on
the extent of soiling
• Inspirited Bacteria Filter See
manufacturer’s recommendation
• Patient Circuit - See manufacturer’s
recommendation - Single use Single patient
• FIO2 Sensor - 14 to 18 months or more
often in case of persistent calibration failure
• Exhalation Block 4 months(*) (and for
each new patient) humidifiers, water traps
• Oxygen solenoid valve - Every 15,000
hours of use
•Turbine - Every 15,000 hours of use
•Exhalation solenoid valve - Every 15,000
hours of use
•Cooling fan - Every 15,000 hours of use
C.2.17

•Clean and disinfect Insp block - Every two

years
•Measurements check and - Every two
years
•calibration - Every two years
•Battery, lithium-ion 4.8 Ah memory - Every
two years
•Battery, lithium, 3V - Every two years
•Buzzer PCBA - Every two years

Is maintenance or calibration Consider: Each time the exhalation block or circuit is Refer to RE00076775 N/A N/A
necessary? • whether maintenance or calibration removed and reinstalled or after installing a Ventilation Hazards
are to be carried out by the operator new exhalation block, the exhalation flow
or user or by a specialist; sensor must be recalibrated before the
using the ventilator. This process is
automatic and does not require the use of a
measurement device.
Each time the FIO2 sensor is removed and
C.2.18

reinstalled, and on a weekly basis, the FIO2

• are special substances or equipment sensor must be recalibrated before using
necessary for proper maintenance or the ventilator. This process does not
calibration? require the use of a measurement device.

Does the medical device contain Consider: whether software is Software is installed by a qualified service N/A N/A N/A
software? intended to be installed, verified, engineer
C.2.19

modified, or exchanged by the

operator or user or by a specialist.

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 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Does the medical device have a Consider: labeling or indicators and N/A N/A N/A N/A
C.2.20

restricted shelf-life? the disposal of such medical devices

when the expiration date is reached.

Are there any delayed or long- Consider: ergonomic and cumulative The patient can become dependent on the Refer to RE00076775 N/A N/A
term use effects? effects. ventilator to provide respiration. Ventilation Hazards
Examples could include pumps for
saline that corrode over time, The ventilator will remain in good service
mechanical fatigue, loosening of straps condition when the preventative
and attachments, vibration effects, maintenance schedule is adhered to
C.2.21

labels that wear or fall off, long term

material degradation.

To what mechanical forces will Consider: whether the forces to which Shipping – ISTA 2A; shock and vibration Refer to RE00076775 N/A N/A
the medical device be subjected? the medical device will be subjected The ventilator is suitable for use in Ventilation Hazards
are under the control of the user or institutional, home, and portable settings. It
controlled by interaction with other is not intended for use as an emergency
C.2.22

persons. transport ventilator. - suitable for use on

commercial aircraft, per FAA requirements

What determines the lifetime of Consider: aging and battery depletion. The lifetime of the device is determined by Refer to RE00076775 N/A N/A
the medical device? a number of factors: Ventilation Hazards
• Life of product line is from inception to
withdraw from market
C.2.23

• Shelf-Life of components is determined by

Stability and Packaging evaluation.

Is the medical device intended for Consider: does the medical device self- No N/A N/A N/A
C.2.24

single use? destruct after use? Is it obvious that

the device has been used?

Is safe decommissioning or Consider: the waste products that are The ventilator is marked to ensure that it Refer to RE00076775 N/A N/A
disposal of the medical device generated during the disposal of the enters the recycled waste system. 'Recycle Ventilation Hazards
necessary? medical device itself. For example, electrical and electronic items with this
does it contain toxic or hazardous marking according to local regulations
C.2.25

material, or is the material recyclable? (EN50419). Do not discard with ordinary

household waste. This includes the
ventilator and the battery.'

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 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Does installation or use of the Consider: the novelty of the medical The ventilator is for use as prescribed by a Refer to RE00076775 N/A N/A
medical device require special device and the likely skill and training doctor. Ventilation Hazards
training or special skills? of the person installing the device.
The ventilator may be operated by:
• Respiratory therapists
• Doctors
• Nurses
• Homecare providers
• Patient and patient’s families
C.2.26

It is the responsibility of the clinician or

clinical educator to ensure that both the
patient and the caregiver fully understand
the daily use of the ventilator.

How will information for safe use Consider: Training and manuals Refer to RE00076775 N/A N/A
be provided? • whether information will be Ventilation Hazards
provided directly to the end user by
the manufacturer or will it involve the
participation of third parties such as
installers, care providers, health care
professionals, or pharmacists, and
whether this will have implications for
training;
C.2.27

• commissioning and handing over to Refer to RE00076775 N/A N/A

the end user and whether it is Ventilation Hazards
likely/possible that installation can be
carried out by people without the
necessary skills;

• based on the expected life of the Refer to RE00076775 N/A N/A

device, whether re-training or re- Ventilation Hazards
certification of operators or service
personnel would be required.

Will new manufacturing Consider: new technology or a new N/A N/A N/A N/A
C.2.28

processes need to be established scale of production.

or introduced?
Is successful application of the Factors that should be considered include user interface design features that can contribute to use error. Features should be designed so that they cannot be easily misused
medical device critically by busy users in an environment where distractions are commonplace, e.g. device control, symbols used, ergonomic features physical design and layout, hierarchy of
C.2.29

dependent on human factors operation, menus for software driven devices, visibility of warnings, and audibility of alarms, standardized color coding.
such as the user interface?

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 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Can the user interface design Factors that should be considered are Yes Refer to RE00076775 N/A N/A
features contribute to use error? user interface design features that can Ventilation Hazards
contribute to use error.
Examples of interface design features
include: control and indicators,
symbols used, ergonomic features,
physical design and layout, hierarchy
of operation, menus for software
C.2.29.1

driven devices, visibility of warnings,

audibility of alarms, and
standardization of color coding. See
IEC 60601-1-6 for additional guidance
on usability and IEC 60601-1-8 for
guidance on alarms.

Is the medical device used in an Consider: Yes Refer to RE00076775 N/A N/A
environment where distractions • the consequence of use error; Ventilation Hazards
can cause use error?
C.2.29.2

• whether the distractions are Refer to RE00076775 N/A N/A

commonplace; Ventilation Hazards
• whether the user can be disturbed Refer to RE00076775 N/A N/A
by an infrequent distraction Ventilation Hazards
Does the medical device have Consider: Yes Refer to RE00076775 N/A N/A
connecting parts or accessories? the possibility of wrong connections, Ventilation Hazards
similarity to other products’
C.2.29.3

connections, connection force,

feedback on connection integrity, and
over- and under-tightening

Does the medical device have a Consider: Yes Refer to RE00076775 N/A N/A
control interface? spacing, coding, grouping, mapping, Ventilation Hazards
modes of feedback,
blunders, slips, control differentiation,
visibility, direction of activation or
C.2.29.4

change, whether the controls are

continuous or discrete, and the
reversibility of settings or actions.

Does the medical device display Consider: Yes Refer to RE00076775 N/A N/A
information? visibility in various environments, Ventilation Hazards
orientation, the visual capabilities of
the user, populations and
C.2.29.5

perspectives, clarity of the presented

information, units, color coding, and
the accessibility of critical information.

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 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

Is the medical device controlled Consider: complexity and number of Yes Refer to RE00076775 N/A N/A
by a menu? layers, awareness of state, location of Ventilation Hazards
settings, navigation method, number
of steps per action, sequence clarity
and memorization problems, and
C.2.29.6

importance of control function relative

to its accessibility and the impact of
deviating from specified
operating procedures.

Will the medical device be used Consider: the user, their mental and Only if the user is differently abled Refer to RE00076775 N/A N/A
by persons with special needs? physical abilities, skill, and training, Ventilation Hazards
ergonomic aspects, the use
environment, installation
requirements, and the patient's
capability to control
or influence the use of the medical
device. Special attention should be
paid to users with special needs, such
as handicapped persons, the elderly,
and children. Their special needs might
C.2.29.7

include assistance by another person

to enable the use of a medical device.
Is the medical device intended to be
used by individuals with various skill
levels and cultural backgrounds?

Can the user interface be used to Consider: the possibility of initiating a yes N/A N/A N/A
initiate user actions? deliberate action for the user to enter
a controlled operation mode, which
C.2.29.8

enlarges the risks for the patient and

which creates awareness for the user
for this condition.

Does the medical device use an Consider: Yes N/A N/A N/A
alarm system? are the risk of false alarms, missing
alarms, disconnected alarm systems,
unreliable remote alarm systems, and
the medical staff’s possibility of
understanding how the
C.2.30

alarm system works. Guidance for

alarm systems is given in IEC 60601-1-
8.

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 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Annex C Questions

In what way(s) might the medical Consider: are incorrect use of User error inputting the prescribed settings Refer to RE00076775 N/A N/A
device be deliberately misused? connectors, disabling safety features User Error - ventilator settings Ventilation Hazards
or alarms, inappropriate for patient
neglect of manufacturer's User Error - not adhering to the PM
recommended maintenance. schedule
User Error - O2 not connected or
obstructed
User Error - cables not connected correctly
User Error - Physical damage from impact
or vibration, or transport bag fault
User Error - environmental temperature or
C.2.31

relative humidity exceeded

User Error - Physical damage from liquid
ingress due to spillage or excessive cleaning
liquid

Does the medical device hold Consider: the consequence of the data Yes Refer to RE00076775 N/A N/A
C.2.32

data critical to patient care? being modified or corrupted. Ventilation Hazards

Is the medical device intended to Consider: necessary grips, handles, Portable Refer to RE00076775 N/A N/A
C.2.33

be mobile or portable? wheels, brakes, mechanical stability, Ventilation Hazards

and durability.

Does the use of the medical Consider: for example, the Yes N/A N/A N/A
device depend on essential characteristics of the output of life-
performance? supporting
devices or the operation of an alarm.
C.2.34

See IEC60601-1-1 for discussion of

performance.

GS10004411, Attachment D
10037183 Rev W Revision 202 Page 13 of 14
 Minimally Invasive Therapies Group System Risk Management
PB500 Series Product Risk Assessment / Risk Analysis Chart - Risk Analysis Chart

RISK ASSESSMENT

RISK ANALYSIS (PRE-

MITIGATION)

Req. ID

PRD296

GS10004411, Attachment D
10037183 Rev. W Revision 202 Page 14 of 14