Module 16 2024

17/10/2024

The basics of risk evaluation

Hazard analysis:

What are the possible causes of an open circuit contact?

• The body of the electrode and the internal wires are too weak – DESIGN FAULT

• A manufacturing laser welding fault can result in an open circuit contact – PRODUCTION FAULT

• The connector block on the EEG cable that connects the Electrode to the EEG monitor if not aligned or closed properly can create a lost contact – USABILITY

• The IFU states that excessively stretching, twisting or folding of the electrode can break the internal wires resulting in lost signals – USABILITY

WHAT QUESTIONS WOULD YOU ASK?

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The basics of risk evaluation

Severity:

Severity No.

Common Term

Description

5

Critical

Death

4

Serious

Results in permanent impairment or irreversible injury

3

Moderate

Results in injury or impairment requiring medical or surgical intervention Results in temporary impairment not requiring medical or surgical intervention

2

Minor

1

Negligible

Results in inconvenience or temporary discomfort

WHAT IS THE SEVERITY OF THE HAZARD?

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