Powerheart® Adult Defibrillation Pads 9131-001 (UDI 00812394020102)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812394020102), received between Mar 10, 2017 and Apr 5, 2018 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionApr 5, 2018Material Separation; Material Separation

  THE NURSE WAS CALLED TO EVALUATE THE CONDITION OF A RESIDENT WHO WAS UNRESPONSIVE AND HAD ASHEN SKIN COLOR. RESIDENT WAS PUT TO BED AND WAS DETERMINED TO HAVE APNEA AND NO CAROTID PULSE. CPR WAS INITIATED AND THE AED WAS APPLIED. WHEN THE PADS WERE REMOVED FROM THE PACKAGING THE ADHESIVE ON THE PADS STUCK TOGETHER AND HAD TO BE PEELED APART. THE ADHESIVE WAS APPLIED TO THE RESIDENT'S SKIN AND THE PAD WAS PLACED ON TOP OF ADHESIVE AND PRESSED ONTO THE ADHESIVE. AFTER ANALYZING THE RESIDENT THE AED PROMPTED THE USER TO CONTINUE CPR. THE EMS ARRIVED, SWITCHED THE AED WITH THEIR OWN, ADMINISTERED IV MEDS, AND SHOCKED THE PATIENT WITH THEIR AED. THE RESIDENT WAS TRANSPORTED TO THE HOSPITAL WITH CPR STILL IN PROGRESS. CUSTOMER REPORTED THAT THE PATIENT HAD EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 7401624 ↗
• DeathMar 10, 2017Detachment Of Device Component; Detachment Of Device Component

  THE AED WAS USED ON A MALE SUBJECT WHO WAS ENTERING THE U.S. FROM (B)(6). WHEN THE CBP OFFICER TRIED TO ADHERE THE DEFIBRILLATION PADS TO THE SUBJECT ONLY ONE PAD STAYED ATTACHED TO HIM. THE ADHESIVE WASN'T ON THE OTHER PAD AND WAS ON THE BLUE COLORED RELEASE LINER. THE USERS ATTEMPTED TO UTILIZED ANOTHER AED THAT WAS IN CLOSE PROXIMITY, HOWEVER, BY THAT TIME THE (B)(6) FIRE DEPARTMENT WAS ONSITE AND TOOK OVER THE RESCUE AND TRANSPORTED THE SUBJECT TO A LOCAL HOSPITAL. THE SUBJECT PASSED AWAY IN ROUTE TO THE HOSPITAL.

  Patient problems: Cardiac Arrest

  MAUDE report 6396521 ↗