Group Deus Ex Machina.
: Aditya Agrawal, Anita Edwards, Almasa Omerovic
Risk Assessment Draft
September 22, 2015
1) Risk Analysis: Intended use/ misuse
List the intended use of the device and any possible reasonable misuses.
The device is meant to assist hemiparesis patients in performing archery. The device
assists the user and makes it easier to pull back and notch an arrow. The device will provide the
support needed to the weakened muscles to ensure the person is able to perform archery without
other assistance. People with various disease and skill levels ages 16 and up can use the device.
Potential misuses are carrying bags/items, to move furniture, and to hold other items.
2) Answer the following questions from ISO 14971 Annex C.
C.2.1 What is the intended use and how is the medical device to be used?
What is the medical device's role relative to?
Muscle activity
What are the indications for use (e.g. patient population)?
Stroke patients, injured upper back/arm patients (car accidents, falling, etc.), genetic
disorders
Does the medical device sustain or support life?
NO.
Is special intervention necessary in the case of failure of the medical device?
No.
C.2.2 Is the medical device intended to be implanted? If yes, describe.
No
C.2.3 Is the medical device intended to be in contact with the patient or other persons? If
yes, describe.
Yes. The device is intended to be work around the torso, similar to a backpack, and underneath
the arms.
C.2.4 What materials or components are utilized in the medical device or are used with, or
are in contact with, the medical device?
The following materials are used in the device: silicone, aluminum, nylon straps, plastic buckles.
C.2.5 Is energy delivered to or extracted from the patient?
Energy is extracted from the patient.
C.2.6 Are substances delivered to or extracted from the patient?
No
C.2.7 Are biological materials processed by the medical device for subsequent re-use,
transfusion or transplantation?
Group Deus Ex Machina.: Aditya Agrawal, Anita Edwards, Almasa Omerovic
Risk Assessment Draft
September 22, 2015
No
C.2.8 Is the medical device supplied sterile or intended to be sterilized by the user, or are
other microbiological controls applicable?
No
C.2.9 Is the medical device intended to be routinely cleaned and disinfected by the user?
Yes
C.2.10 Is the medical device intended to modify the patient environment?
No
C.2.11 Are measurements taken?
Measurements are taken to fit the device to patient.
C.2.12 Is the medical device interpretative?
No
C.2.13 Is the medical device intended for use in conjunction with other medical devices,
medicines or other medical technologies?
No
C.2.14 Are there unwanted outputs of energy or substances?
No
C.2.15 Is the medical device susceptible to environmental influences?
Yes
C.2.16 Does the medical device influence the environment?
No
C.2.17 Are there essential consumables or accessories associated with the medical device?
No
C.2.18 Is maintenance or calibration necessary?
Yes, maintenance is necessary.
C.2.19 Does the medical device contain software?
No.
C.2.20 Does the medical device have a restricted shelf-life?
No.
Group Deus Ex Machina.: Aditya Agrawal, Anita Edwards, Almasa Omerovic
Risk Assessment Draft
September 22, 2015
C.2.21 Are there any delayed or long-term use effects?
No
C.2.22 To what mechanical forces will the medical device be subjected?
Weight of the arms, bow and arrow; shearing force from the locking mechanism; stress on the
joints do to total weight and due to bow resistance; shearing force on the surface of the skin or
clothes; friction;
C.2.23 What determines the lifetime of the medical device?
Proper maintenance, no misuse of the device, frequency of use.
C.2.24 Is the medical device intended for single use?
No.
C.2.25 Is safe decommissioning or disposal of the medical device necessary?
No
C.2.26 Does installation or use of the medical device require special training or special
skills?
No.
C.2.27 How will information for safe use be provided?
Users manual, warning labels.
C.2.28 Will new manufacturing processes need to be established or introduced?
No.
C.2.29 Is successful application of the medical device critically dependent on human factors
such as the user interface?
Yes.
C.2.29.1 Can the user interface design features contribute to use error?
Yes.
C.2.29.2 Is the medical device used in an environment where distractions can cause use
error?
Yes.
C.2.29.3 Does the medical device have connecting parts or accessories?
No.
C.2.29.4 Does the medical device have a control interface?
Group Deus Ex Machina.: Aditya Agrawal, Anita Edwards, Almasa Omerovic
Risk Assessment Draft
September 22, 2015
No.
C.2.29.S Does the medical device display information?
No.
C.2.29.S Is the medical device controlled by a menu?
No
C.2.29.7 Will the medical device be used by persons with special needs?
Yes.
C.2.29.S Can the user interface be used to initiate user actions?
No
C.2.30 Does the medical device use an alarm system?
No
C.2.31 In what way(s) might the medical device be deliberately misused?
To injure other individuals, use device to shoot the arrow at objects not a target.
C.2.32 Does the medical device hold data critical to patient care?
No.
C.2.33 Is the medical device intended to be mobile or portable?
Yes.
C.2.34 Does the use of the medical device depend on essential performance?
No.
Group Deus Ex Machina.: Aditya Agrawal, Anita Edwards, Almasa Omerovic
Risk Assessment Draft
September 22, 2015
Table 3: Hazard Traceability Matrix
I
D
Hazard
Reasonably foreseeable
sequence or combination of
events
Hazardous
Situation
Harm
Proba
bility
Seve
rity
Accep
table
Locking Joints
Finger or object stuck in joint
while pulling back
Pinched or broken
finger, or
malfunction
Extremit
y harm
Acc*
Ratchet
Mechanism
fails to lock
User pulls back expecting it lock,
but doesn't
loss of control
and device failure
User
unable
to use
device
Acc
Device not
properly
secured
Device not strapped correctly or
tightly enough
Injury from
device as it comes
off the user
Bodily
injury
Acc*
Button that
releases joint
User unable to press button
stuck in locked
position
Acc
Strapstightly
wrapped on arm
Person wears device to tightly
Acc*
Weight of
device
User wears the device even
though it is too heavy
Bodily
injury
Acc*
Continuous
wear of device
Wear device continuously, which
causes friction between skin and
device
Skin
reaction
Acc
Blood flow
blockage
Person collapses
under weight of
device
Rash,
uncomfortable
skin reaction
Uncomf
ortable
position
Bodily
Harm
Table 3: Risk Evaluation Matrix
Probability
Severity
1
2
3
4
5
R4
R7
R1
R2
R6
R3
R5
