Quality in Design - Medical Device Design: Innovation from Concept to Market - page 141

Table 7.14: Example FMEA

Rating Remedial

1 Display shows insulin

is being infused but no
insulin is entering the
body.

Patient can
suffer diabetes
related episode.

A flat battery
causes pump
to fail while
maintaining
display activity.

4 4 5 80

Occurrence

Detect = 5 1 2 3 4 5

1 5 10 15 20 25

2 10 20 30 40 50

3 15 30 45 60 75

4 20 40 60 80 100

5 25 50 75 100 125

Before

Occurrence

Detect = 1 1 2 3 4 5

1 1 2 3 4 5

2 2 4 6 8 10

3 3 6 9 12 15

4 4 8 12 16 20

5 5 10 15 20 25

After

Rating Remedial

1 Display

shows insulin
is being
infused but
no insulin is
entering the
body.

Patient
can
suffer
diabetes
related
episode.

A flat battery
causes pump
to fail while
maintaining
display
activity.

4 4 5 80 Low battery warning

(buzzer) included to
activate when 2 hours
battery life remaining;
emergency battery
pack supplied; charger
designed to be portable
(handbag / pocket size).

4 2 1 8