Number:

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FMEA - 1

Revision:

Wheelchair-Mounted Transfer Assist Device

Failure Mode Effect Analysis

UNCONTROLLED DOCUMENT UNLESS ISSUED WITH A RED STAMP

This document is the confidential property of the Wheelchair-mounted transfer
assist device group and may not be reproduced without prior written consent
Revision Approvals:
Author
Clinical
Engineering
Quality Assurance
General Management

Michael Anderson, Andrew Feola, Jill Marion, and

Bryan Shelly
Alicia Koontz, PhD, RET and Jeremy Puhlman, BSE
Michael Anderson and Andrew Feola
Jill Marion, and Bryan Shelly
Michael Anderson, Andrew Feola, Jill Marion, and
Bryan Shelly

STAMP HERE
Date
4/18/2006
4/18/2006
4/18/2006
4/18/2006
4/18/2006

Risk Index notes: The risk index in the FMEA below is used to classify the likelihood of
the associated hazard, not the severity. Likelihood of failure of a component is rated with
1 meaning that failure is extremely likely and 5 meaning that failure is extremely unlikely
Component Failure
Mode

Effect on
System

Possible
Hazards

Casing

Repetitive
stress to
failure

Repeated
loading
causes
deformation

Casing

Ultimate
stress

Large onetime load

causes
deformation

Sliding
transfer
board

Cyclic
stress to
failure

Transfer
board no
longer
slides out

Casing
bends
and
patient
falls
Casing
could
break off,
person
could fall
Patient
cannot
make a
transfer

Transfer

Ultimate

Large one-

Transfer

Risk
Index
(1-5
where
1 is
most
likely)
4

User
Detection
Means

Applicable
Controls

Visual
sighting of
problem

Use a
strong
enough
material

No
detection.
Will occur
during use

Use a
strong
enough
material

User will
no longer
be able to
slide
transfer
board out
No

Lubricate
the sliding
track, use
proper
durable
materials
Use a

board

stress

Locking
mechanism

Lock
breaks
due to
deformation

Device/
chair
interface

time load
causes
deformation

Person
moving/ not
able to
perform
stable
transfer
Device
Device
becomes
becomes
unloose,
attached
transfer not
from chair stable

Casing joint

Two
casing
pieces
come
apart

Transfer
impossible

Sliding
hinge

Cyclic
stress to
failure

Transfer
board cant
slide out of
armrest
casing

board
bends or
breaks,
patient
falls
Board
moves
during
transfer,
patient
falls
Person
could fall
from
chair

Patient
falls
during
transfer
when
casing
breaks
Person
cannot
perform
transfer,
stuck in
chair

detection.
Will occur
during use.

strong
enough
material.

Person will
feel the
board
move even
when its
locked
User will
feel the
device
moving,
not being
rigid

Use
multiple
locks, use
strong locks

User could
notice
weakened
joint

Transfer
board
wont slide
out

Use plenty
of
screws/bolts
during
attachment
of device.
Weld device
to chair.
Use strong
bolts,
multiple
bolts

Keep
sliding
hinges
properly
lubricated