HeartStart Pads 989803125401Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838002876), received between Apr 5, 2021 and Mar 8, 2023 — classified as 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 2 most recent of 2 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 NUMBERSM3718A. AS PART OF THE PROJECT, THE HAZARDOUS SUBSTANCE COMPLIANCE EVIDENCE WAS UPDATED. ON 25-JAN-2023, IT WAS DISCOVERED THAT THE NEW SUPPLIER'S WIRING INSULATION OF THE CONNECTOR ASSEMBLIES USED TO MANUFACTURE M3718A 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 M3718A 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 16507188 ↗
• MalfunctionApr 5, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED TO PHILIPS THAT THE M3718A PADS WERE DELIVERED WITH THE SAME ILLUSTRATION PRINTED ON THE LEFT AND RIGHT PADS. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. THE MANUFACTURER'S BENCH REPAIR TECHNICIAN EVALUATED THE DEVICE AND CONFIRMED THE REPORTED PROBLEM. THE ALLEGATION WAS VERIFIED - THIS ADULT/CHILD RADIOTRANSPARENT MULTIFUNCTION ELECTRODE PADS WERE RECEIVED WITH THE WRONG ARTWORK. ON THE INFANT RADIOTRANSPARENT MULTIFUNCTION ELECTRODE PADS, ONLY THE POSTERIOR LABEL WAS REPRESENTED ON BOTH THE PADS; THERE WAS NO ANTERIOR LABEL ILLUSTRATED. SIMILARLY, ONLY THE STERNUM LABEL WAS REPRESENTED ON BOTH ADULT RADIOTRANSPARENT MULTIFUNCTION ELECTRODE PADS; THERE WAS NO APEX LABEL ILLUSTRATION. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE ELECTRODE PADS. THE PADS HAVE BEEN SCRAPPED. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN INITIATED. AN INVENTORY SAMPLING FOUND NO DEFECTS. THE SUPPLIER HAS ISSUED A QUALITY ALERT TO PROMOTE AWARENESS. THE CAUSE WAS DETERMINED TO BE ASSEMBLY ERROR. NO FURTHER EVALUATION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614669 ↗