HeartStart Pads 989803125411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838002883), received between Nov 24, 2021 and Mar 8, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2023Degraded; Degraded

  THE PADS CONNECTOR PROJECT CHANGED THE ALS PADS CONNECTOR ASSEMBLY SUPPLIER (TIER 2) FOR PART NUMBER M3719A. AS PART OF THE PROJECT, THE HAZARDOUS SUBSTANCE COMPLIANCE EVIDENCE WAS UPDATED. ON (B)(6) 2023, IT WAS DISCOVERED THAT THE NEW SUPPLIER'S WIRING INSULATION OF THE CONNECTOR ASSEMBLIES USED TO MANUFACTURE M3718A AND M3719A PADS WIRING INSULATION CONTAINS A PVC COMPOUND MATERIAL COMPRISED OF 20-30% DEHP MATERIAL. THIS MATERIAL HAS BEEN USED SINCE INITIAL PRODUCTION RELEASE. THIS LEVEL OF DEHP MATERIAL DOES NOT COMPLY WITH THE FOLLOWING REGULATIONS: ROHS2; ROHS3; PROPOSITION 65; REACH. PHTHALATES HAVE BEEN IN THE M3719A WIRE INSULATION MATERIAL SINCE INITIAL PRODUCTION RELEASE. THERE WAS NO PATIENT INVOLVEMENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507793 ↗
• MalfunctionNov 29, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO PHILIPS THAT, WHEN THE CUSTOMER TRIED TO USE THE X-RAY TRANSMISSION TYPE PEDIATRIC DEFIBRILLATION PAD M3719A, THE GEL PEELED OFF FROM THE PAD SIDE AND REMAINED ON THE MOUNT. THE NEXT M3719A PREPARED IN SUCCESSION WAS IN THE SAME STATE. THE FIRST PAD IS BEING ADDRESSED IN (B)(4). THE SECOND PAD IS ADDRESSED HERE IN (B)(4). THE PADS WERE BEING USED TO MONITOR A PATIENT. THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO ADVERSE EVENT TO PATIENT OR USER. THE INFANT RADIOTRANSPARENT MULTIFUNCTION ELECTRODE PADS WERE RETURNED FOR FAILURE ANALYSIS. THE INFANT RADIOTRANSPARENT MULTIFUNCTION ELECTRODE PADS WERE RECEIVED WITH SIGNIFICANT UNUNIFORM GEL SURFACE AND SIGNS OF AIR/BUBBLES BETWEEN THE GEL AND THE CLEAR PLASTIC LINER. THE REPORTED PROBLEM WAS VERIFIED IN THE LAB. THE STERNUM PAD PRESENTED SIGNIFICANT UNUNIFORM GEL SURFACE AND THE APEX PAD SHOWED SIGNS OF AIR/BUBBLES BETWEEN THE GEL AND THE CLEAR PLASTIC LINER RESULTING IN PADS FAILING TESTS. THE REPORTED ISSUE WAS CONFIRMED. THE INFANT RADIOTRANSPARENT MULTIFUNCTION ELECTRODE PADS WERE SCRAPPED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885868 ↗
• MalfunctionNov 24, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO PHILIPS THAT, WHEN THE CUSTOMER TRIED TO USE THE X-RAY TRANSMISSION TYPE PEDIATRIC DEFIBRILLATION PAD M3719A, THE GEL PEELED OFF FROM THE PAD SIDE AND REMAINED ON THE MOUNT. THE NEXT M3719A PREPARED IN SUCCESSION WAS IN THE SAME STATE. THE FIRST PAD IS BEING ADDRESSED IN PR (B)(4). IT WAS INITIALLY REPORTED THAT THERE MAY HAVE BEEN A DELAY IN LIFE SAVING THERAPY, HOWEVER, IT WAS LATER CLARIFIED BY EMAIL FROM TECHNICAL SUPPORT THAT THE CUSTOMER WAS MONITORING A PATIENT AT THE TIME OF THE ISSUE. THEREFORE, THIS REPORT HAS BEEN UPDATED FROM A SERIOUS INJURY TO A PRODUCT PROBLEM. THE SECOND PAD IS ADDRESSED IN PR (B)(4). THE CUSTOMER CONTACTED THE PHILIPS RESPONSE CENTER. THE CUSTOMER SHIPPED THE INVOLVED PAD SET TO PHILIPS FOR EVALUATION. ONE DEFIBRILLATION PAD SET WAS RETURNED FOR FAILURE ANALYSIS. THE REPORTED PROBLEM WAS VERIFIED. THE STERNUM PADS PRESENTED SIGNIFICANT UN-UNIFORM GEL SURFACE AND THE APEX PADS SHOWED SIGNS OF AIR/BUBBLES BETWEEN THE GEL AND THE CLEAR PLASTIC LINER RESULTING IN PADS FAILING TESTS. THE REPORTED PROBLEM WAS VERIFIED. THE PAD SET WILL BE SCRAPPED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12871559 ↗