Serious Adverse Events vs Malfunctions

Serious adverse event (중대한 이상사례)

Requires actual patient harm: death or serious deterioration of health attributable to or possibly attributable to the device.

Reportable malfunction (보고 대상 오작동)

Does not require actual harm — a malfunction that could cause death or serious injury if it recurred. This is a prospective, risk-based criterion.

Examples:

• A pump intermittently delivering incorrect doses (no harm yet, but could cause harm)
• A diagnostic device producing incorrect results (no patient harmed this instance)

Decision guide

1. Death or serious patient injury? → Serious adverse event (15-day report)
2. Malfunction that could cause death/serious injury if recurring? → Malfunction report (30-day)
3. Neither? → Investigate, record, include in trend monitoring

Related pages

• What must be reported · Reporting timeframes