LIFEPAK® 500 Automated External Defibrillator 99401 (REF 99401-000840)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902655203), received between Jan 30, 2019 and Jan 30, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Connection Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJan 30, 2019Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE CONTINUOUSLY GAVE A ¿CONNECT ELECTRODES¿ MESSAGE AND WAS UNABLE TO ANALYZE THE PATIENT RHYTHM. THE DEVICE WAS BEING USED ON A PATIENT AND THEY HAD PHYSIO-CONTROL BRANDED DEFIBRILLATION ELECTRODES CONNECTED TO THE PATIENT. THERE WAS A 12-15 MINUTE DELAY BEFORE EMS PERSONNEL ARRIVED ON THE SCENE WITH A BACK-UP DEVICE. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT HAVE BEEN AVAILABLE, IF IT WAS NEEDED. THE EMS PERSONNEL BELIEVE THE ISSUE WAS CAUSED BY THE PATIENT'S HAIRY CHEST, PROFUSE SWEATING, AND A LACK OF SKIN PREP PERFORMED BY THE INITIAL RESPONDERS. OVER 30 MINUTES OF CPR WAS PERFORMED ON THE PATIENT DURING THE EVENT. THE EMS PERSONNEL SHAVED THE PATIENT'S CHEST WHEN THEY ARRIVED, PERFORMED ADDITIONAL SKIN PREP, AND WERE ABLE TO GET A PATIENT CONNECTION AND RHYTHM. THE BACK UP DEVICE INDICATED NO SHOCK ADVISED. THE PATIENT IS DECEASED. THE CUSTOMER DOESN'T KNOW IF THE DEVICE USE CONTRIBUTED TO THE OUTCOME OF THE PATIENT SINCE THEY WERE UNABLE TO ANALYZE THE PATIENT'S RHYTHM FOR 12-15 MINUTES DURING THE EVENT.

  Patient problems: Death

  MAUDE report 8291397 ↗