PHILIPS HeartStart SMARTPADS III Smart Pads IIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838023765), received between Jan 10, 2023 and Sep 6, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT HAS BEEN REPORTED TO PHILIPS THAT AT LEAST 12 PACKS OF PADS FAILED DUE TO ADHESIVE ON PAD NOT STICKING TO PATIENT AND PEELING AWAY FROM THE PAD ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692725 ↗
• MalfunctionMar 9, 2023Loss of or Failure to Bond

  DURING CHEST COMPRESSIONS, THE PADS DID NOT ADHERE APPROPRIATELY TO THE PATIENT'S SKIN AND WERE "SLIDING AROUND" DURING RESUSCITATION ATTEMPTS. PER PHILLIPS, THEY NEED TO DETERMINE IF THIS ISSUE NEEDS A NEW CASE NUMBER OR IF IT CAN BE ADDED TO A PREVIOUS COMPLAINT ASSOCIATED WITH THE SAME PADS.

  Patient problems: Insufficient Information

  MAUDE report 16512025 ↗
• MalfunctionMar 9, 2023Adverse Event Without Identified Device or Use Problem

  NOTED RED SKIN BURN TYPE MARKS TO PATIENT'S RIGHT UPPER AND LOWER CHEST WHERE PADS WERE IN PLACE. PER PHILIPS, NEED TO DETERMINE IF A NEW CASE NUMBER IS NEEDED OR IF THIS CAN BE ADDED TO AN EXISTING COMPLAINT RELATED TO PAD USE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16512000 ↗
• MalfunctionMar 9, 2023Use of Device Problem

  CATH LAB NURSE NOTED PADS WERE IN PLACE AND APPEARED ADHERED TO SKIN DURING CATH LAB PATIENT PREP.  DURING CATH LAB INTERVENTION, PATIENT WENT INTO V FIB AT 00:02.  PATIENT SHOCKED AT 150 JOULES IN LESS THAN 10 SECOND OF RHYTHM CHANGE.  REMAINED IN V FIB, 4 ADDITIONAL SUBSEQUENT SHOCKS GIVEN AT 200 JOULES WITHOUT CONVERSION TO PERFUSING RHYTHM.  CPR STARTED AND ROSC ACHIEVED 00:04.  ATTENDING CATH LAB PHYSICIAN COMMENTED ON CONCERN WITH THE DEFIBRILLATOR PADS AND THE INABILITY TO CONVERT THE PATIENT OUT OF V FIB. PATIENT'S ELECTROLYTES WERE WITHIN NORMAL LIMITS. WHEN PADS REMOVED POST PROCEDURE IN ICU, RED SKIN/BURN TYPE MARKS NOTED ON PATIENT'S RIGHT UPPER CHEST (WHERE PAD LOCATED) AND LEFT LOWER CHEST OUTLINED MARKS. PER PHILIPS, NEED TO DETERMINE IF THEY NEED TO OPEN A NEW CASE NUMBER OR IF THIS CAN BE ADDED TO PREVIOUS COMPLAINTS RELATED TO THE PADS.

  Patient problems: Superficial (First Degree) Burn; Ventricular Fibrillation

  MAUDE report 16511999 ↗
• InjuryJan 10, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT WAS GETTING A CARDIOVERSION AND IT WAS FOUND THAT THE NEW DEFIB PADS DO NOT STICK LIKE THE OLD ONES DID. MEDICAL DOCTOR HAD TO TAPE DOWN THE EDGES OF THE DEFIB PADS TO ENSURE PROPER CONTACT WITH THE SKIN. PT WAS SHAVED BEFORE THE DEFIB PADS WERE PLACED. AFTER THE CARDIOVERSION, PT FOUND TO HAVE GOTTEN BURNED ON HIS CHEST FROM THE SHOCK. BURN WAS DRESSED WITH BACITRACIN AND NONSTICK DRESSING.

  Patient problems: Burn(s)

  MAUDE report 16133739 ↗