INJURY RISK ASSESMENT OF CM BED

USE FAILURE MODE AND EFFECT

ANALYSIS ( ?
 ) FOR SYSTEM AND
DESIGN OF THE BED

by Susanto
Background
j Quality assurance of product must be
guaranteed not only by On Line Quality
Control activity in the Production Line but
early since in the stage of design and
development. Which is call as Of Line
Quality Control
j Prediction of failure probability of product
is a part of Of Line Quality Control
Failure Mode and Effect Analysis
j Method to describe probability of failure of
a product
j How the failure can be happen
j How far severity of the failure
j What are the effect of the failure to the
user, system and environment
j How failure occurrence can be detected
Harmonized Standard
j ISO 9001 : 2000 ; Quality Management
System
j ISO 13485 : 1996; Quality System Medical
Devices - Particular requirements for
application of ISO 9001
j EN 1441 :1997 ; Medical Devices - Risk
Analysis
j 93/42/EEC Medical Devices Directive
 PROSEDUR FMEA
Identified and analyze
Function
Of theof system
the system

Define mode of failure

Describe effect of Failure

Determine potential source of failure

Determination occurrence Evaluating detection method Determine Severity

rating rating


Determine detection rating

Calculating RPN (




 )

Is risk acceptable ?

6

Risk reduction/correction recommendatio

M odification data
M odification

?
 
?
?


Risk Priority Number (RPN)
j RPN is Degree of Failure Risk
j RPN = Rating of Severity x Rating of
Occurrence x Rating of Detection method
j RPN = 1 Lowest Risk
j RPN = 1000 Highest Risk
 Severity Rating Table
Y

 
Y

Effect Rating Criteria
No effect
No Effect 1

Customer not annoyed. Very slight effect on product or System

Very Slight Effect 2
performance
Customer slightly annoyed. Slight effect on product or System
Slight Effect 3
performance
Customer experiences minor annoyed. Minor effect on product
Minor Effect 4
or System performance
Customer experiences some dissatisfaction. Moderate effect on
Moderate Effect 5
product or System performance
Customer experiences discomfort. Product performance degraded
Significant Effect 6
but operable and safe. Partial loss of System function but operable
Customer dissatisfied. Product performance severely affected
Mayor Effect 7
but driveable and safe. System function impaired
Customer very dissatisfied. Product in operable, but safe
Extreme Effect 8
System inoperable
Potential hazardous effect. Able to stop product without mishap -
Serious Effect 9
gradual failure.
Hazardous effect. Safety related - sudden failure.
Hazardous Effect 10
 Occurrence Rating Table
Y


 
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 Detection Rating Table
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CM BED
Function of The Bed



  


  
  




 


 


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 FunctionStructure

E
Patient Placing the Supporting Adjusting
patient the load position of
BED the bed Manual
force

Patient Transporting
Parking the bed

Manual Manual
force force

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 Placing the Patient




 
 






  


 


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 Parking The Bed
brake
Bed+Patient

Placing the Locking the

bed wheels
Bed +Patient
Manual
Force
Fig 8: Parking the bed
 CM BED FUNCTION
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Castor Testing
Result of Castor Testing
Y  Y  







Type Castor Testing Result Remark
time
(minute)
0.5 good
1 Yield Wheel out begin to loose from wheel in
one side
Castor
2 Yield
Haibam
two side
6 Broken Wheel out broken and loose from wheel
in. Life ability = 6*255=1530m
<11 Good
20 Begin Temperature of wheel out rise and
damage wheel out begin to soft
Castor TPU
Wheel out begin to yield, temperature
30 Broken rise significantly wheel out to hot. Live
ability = 30 * 255 =7650m
Y 


 


     
 
Y  Y  
! 
 



Type Castor time Result Remark
(minute)
Castor 2 Broken Wheel out yield and loose from wheel
Haibam in
100 Good Wheel out and all the structure of
Castor TPU Castor steel in good condition. Life
ability >100*255=25500 m=25.5 km
Castor Haibam
Castor TPU
 Result of Bed Testing
Mode test Load (N) Result

Safe load 1700 The bed able to receive safe load

Mattress/ bed motion 1700

u High low Spindle, handle connector and bearing failure
u Knee raise, Back raise Good condition, no failure

Castor 1700/4 Castor capable to support load with normal barrier

Crash testing 1700 There is no shape change and deformation after crash

Pull and push force 900 The bed can moved by 150 N Forces

Head & foot panel 450 Head & foot capable receive load

Impactor 250 The mattress platform capable receive impact load without shape
change and deformation
Loading pad 880 The bed capable receive load without deformation

Static testing 4000 The bed loaded for 1 hour, when loaded there is any static deformation
in the bed, but after load release the bed back to original position.
Conclusion and Recommendation

From the risk analysis and testing result the most risky
mode of failure are failure of castor and spindle pair for
high-low motion.
The potential effect of the failure is make user very
dissatisfied and the system inoperable. There is no
injury risk to the user or sudden failure to the system.
Suggested to used Castor TPU to change Castor
Haibam
As soon as possible to take action for take corrective
action to improve spindle pair for hi-low motion.