Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Clinical/Biomedical Engineering; Home Healthcare; Nursery; Nursing

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Burn (electrical, thermal, chemical); Electrical shock / electrocution; Monitoring failure

Support System Failures
Poor prepurchase evaluation

Tampering and/or Sabotage
*Not stated

User Errors
Improper connection; Inappropriate reliance on an automated feature

Apnea Monitors [12-575]

Infant Home Apnea Monitors: Essential Safety Features and Practices (Update)

Hazard Update [Health Devices Dec 1993;22(12):598-601]

Essential Safety Features

  • Heartbeat Detector
  • Remote Alarm
  • Power-Loss Alarm (nonbattery-operated units)
  • Safe Electrodes (wires cannot be plugged into electrical cords or outlets)

If the monitor lacks these features: Keep using it, follow safety practices below, and replace or modify unit as soon as possible.

Essential Safety Practices

Daily: Check monitor and remote alarm sounds by disconnecting leads. Use monitor self-test feature if available.

During monitoring: Always check baby any time monitor alarms, even if alarm stops. If possible, operate from an electrical outlet. Be sure power cords and cables are plugged in. The breath-detection light should blink once for each breath. The heartbeat light should blink in a consistent pattern. Immediately report unusual operation.

Monitor placement: Never place monitor on floor. Do not place items near monitor; they might block displays or muffle alarms. Place monitor several feet from electrical devices.

Baby's bed: No parents, children, or pets should sleep in same crib or bed with baby.

Monitor settings: Only your doctor or home care provider should change monitor settings.

Training and support: You should be trained in proper monitor use and CPR. Have your home care service regularly check the monitor.


Apnea Monitors [12-575]

Cause of Device-Related Incident

Device factor: Design/labeling error

User errors: Improper connection; Inappropriate reliance on an automated feature

Support system failure: Poor prepurchase evaluation

Mechanism or Injury or Death

Burn (electrical); Electrical shock/electrocution; Monitoring failure 


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