inforMED
MalfunctionDSA

LIFEPAK ECG CABLES FOR LIFEPAK 3

Received Jan 14, 2026 · Event occurred Dec 15, 2025

Report MW5182222 · MDR key 24067562

Device

Generic name

Cable, Transducer And Electrode, Patient, (including Connector)

Lot number

524

Product problems

  • Failure to Sense
  • Therapeutic or Diagnostic Output Failure

Patient

64 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING A 911 RESPONSE, THE CABLES FOR OBTAINING BOTH 4-LEAD AND 12-LEAD ECGS WERE NOT FUNCTIONING. THE DEVICE, USED ON AN AMBULANCE, HAD UNDERGONE TROUBLESHOOTING BUT WAS UNABLE TO PERFORM AN ECG AS INDICATED FOR PATIENT CARE. THIS PREVENTED DETERMINATION OF THE PATIENT'S CARDIAC RHYTHM AND DELAYED APPROPRIATE TREATMENT BASED ON 12-LEAD ECG RESULTS. THE ISSUE APPEARS SPECIFIC TO THE CABLES, NOT THE MONITOR ITSELF. PATIENT: 4582. DEVICE: 3023;1559. REFERENCED REPORTS: MW5182223.