LIFEPAK® 500 Automated External Defibrillator 99401 (REF 99401-001084)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885074753980), received between Mar 18, 2019 and Sep 17, 2019 — classified as 3 deaths, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathSep 17, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT A USE ERROR OF SELECTING THE POWER BUTTON INSTEAD OF THE ANALYSE BUTTON CAUSED A 2 MINUTE DELAY IN CARE AND MAY HAVE CAUSED OR CONTRIBUTED TO A PATIENT DEATH.

  Patient problems: Death

  MAUDE report 9078793 ↗
• DeathAug 9, 2019Connection Problem; Impedance Problem; Connection Problem; Impedance Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND IT DISPLAYED A ¿CONNECT ELECTRODES¿ MESSAGE. THIS LED TO OVER A 6 MINUTE DELAY IN THE TREATMENT OF THE PATIENT. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF IT WAS NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

  Patient problems: Death

  MAUDE report 8880615 ↗
• DeathAug 9, 2019Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND IT DISPLAYED A CONNECT ELECTRODES¿ MESSAGE. THIS LED TO OVER A 6 MINUTE DELAY IN THE TREATMENT OF THE PATIENT. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF IT WAS NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

  Patient problems: Death

  MAUDE report 8878773 ↗
• MalfunctionMar 18, 2019Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE A PATIENT CONNECTION. THE DEVICE CONTINUED TO GIVE THE CONNECT ELECTRODES PROMPT EVEN AFTER THE ELECTRODES WERE PROPERLY ATTACHED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED; HOWEVER, IT WAS NOT DUE TO THE REPORTED ISSUE. THE PATIENT HAD A DO NOT RESUSCITATE ORDER.

  Patient problems: No Patient Involvement

  MAUDE report 8430180 ↗