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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 to have occurred — a malfunction that could potentially cause death or serious injury if it were to recur. This is a prospective, risk-based criterion that focuses on the potential for harm rather than realized harm.

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