HeartStart Adult/Child Plus Pads Heartstart Pads (REF M3713A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838002845), received between Oct 18, 2022 and Mar 17, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2024Component Misassembled; Component Misassembled

  IT HAS BEEN REPORTED THAT 16 PAD SETS HAD ONE OF THE PADS STUCK TO THE LINER. ALL PAD SETS WERE DISCARDED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919259 ↗
• MalfunctionJul 5, 2023Degraded; Material Integrity Problem; Degraded; Material Integrity Problem

  PHILIPS RECEIVED A COMPLAINT ON THE PHILIPS M3713A MULTIFUNCTION ADULT/CHILD ELECTRODE PADS PLUS INDICATING THAT A SET OF PADS WAS UNUSUALLY STICKY, AND IT WAS DIFFICULT TO CLEAN THE GEL OFF OF THE PATIENT AFTER USE. THERE WAS REPORTEDLY NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259545 ↗
• InjuryJan 3, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED TO PHILIPS THAT, DURING A CARDIAC ARREST, ELECTRODE PADS M3713A WERE APPLIED TO THE PATIENT AND CONNECTED TO THE DEFIBRILLATOR. THE PATIENT HAD REGAINED PULSE AND WAS IN ARRHYTHMIA. AFTER CONNECTING TO THE DEFIBRILLATOR, THE DEVICE WOULD NOT CHARGE. THE DEVICE WAS SWAPPED FOR TWO OTHER DEVICES. THE NEW PADS WERE APPLIED TO GET A SUCCESSFUL CARDIOVERSION. ADDITIONAL DETAILS HAVE BEEN REQUESTED. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.

  Patient problems: Cardiac Arrest

  MAUDE report 16092408 ↗
• InjuryOct 18, 2022Peeled/Delaminated; Peeled/Delaminated

  IT HAS BEEN REPORTED THAT THE PADS STUCK TO THE LINER WHEN ATTEMPTING TO BE USED FOR A PATIENT USE EVENT. THE USER WAS ABLE TO REPLACE THE PADS WITH A SPARE SET. THERE ARE NO KNOWN CONSEQUENCES OR HEALTH IMPACT TO THE PATIENT

  Patient problems: Cardiac Arrest

  MAUDE report 15620801 ↗