MISC - Severity or Consequences Rating

Question 1

No impact at all on product performance or patient safety (Severity or consequences rating)

Answer 1

1 (None)

Question 2

Patient not concerned; No patient injury; No noticeable effect on
product performance (Severity or consequences rating)

Answer 2

2 (Minor inconvenience)

Question 3

Patient not concerned; No patient injury; Slight/cosmetic effect on
product performance; May result in minor complaint (Severity or consequences rating)

Answer 3

3 (Moderate inconvenience)

Question 4

Customer experiences some minor nuisance and becomes slightly
annoyed; Complaint probable but no patient injury (Severity or consequences rating)

Answer 4

4 (Minor dissatisfaction)

Question 5

Moderate user dissatisfaction, No patient injury; Performance
degraded, but product remains safe and operable (Severity or consequences rating)

Answer 5

5 (Moderate dissatisfaction)

Question 6

Major user dissatisfaction, product non-performance evident but safe,
no resulting injury to patient (Severity or consequences rating)

Answer 6

6 (Major dissatisfaction)

Question 7

A failure that can cause transient adverse reaction to a patient and
compliant; May not require treatment and has no long-term health consequences (Severity or consequences rating)

Answer 7

7 (Marginal health hazard)

Question 8

A failure that can cause a moderate harm or adverse reaction to a
patient or user but will not result in chronic harm; The harm will require treatment (Severity or consequences rating)

Answer 8

8 (Moderate health hazard)

Question 9

A failure that can contribute (indirectly) to a death or severe or chronic harm, Product performance is degraded (Severity or consequences rating)

Answer 9

9 (Critical health hazard)

Question 10

A failure that can by itself cause (directly) death or a significant harm to a patient or user (Severity or consequences rating)

Answer 10

10 (Catastrophic health hazard)