Table 1 Events scale with its description and corresponding severity
From: Establishment of a medical device adverse event management system for hospitals
Event Scale | Description | Severitya (0–1) |
|---|---|---|
General Event | No damage occurred; defects of products can possibly be found through pre-use inspection | 0.1 |
Serious Event | Slight damage happened or is likely to occur if the event would happen again. It can be cured via simple treatment | 0.4 |
Permanent damage or harm can be avoided only through treatment | 0.5 | |
Permanent damage or harm is possibly to happen | 0.6 | |
Permanent damage or harm happened | 0.8 | |
Life-threatening | 0.9 | |
Extreme Event | Causing death; or damage occurred simultaneously on a group of people (more than 3 persons) | 1 |