LIFEPAK® 500 Automated External Defibrillator 99401 (REF 99401-000210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902172557), received between Mar 1, 2019 and May 7, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2019Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER, A HEALTHCARE PROVIDER, CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE WAS UNABLE TO DETECT THE PATIENT THROUGH THE DEFIBRILLATION ELECTRODES. THE CUSTOMER ADVISED THAT THE DEVICE PROMPTED THEM TO ¿CONNECT ELECTRODES¿ WHEN THE DEFIBRILLATION ELECTRODES WERE CONNECTED TO THE PATIENT. THE SAME DEFIBRILLATION ELECTRODES WERE CONNECTED TO BACKUP AED THAT WAS ON THE SCENE, AND THE THAT DEVICE WORKED PROPERLY. IT IS UNKNOWN IF SKIN PREP WAS PERFORMED PRIOR TO APPLYING THE DEFIBRILLATION ELECTRODES. THE CUSTOMER ALSO ADVISED THAT THE DEFIBRILLATION ELECTRODES WERE NOT EXPIRED. THE PATIENT, A (B)(6) YEAR OLD MALE DID NOT SURVIVE. THE CUSTOMER, A HEALTH CARE PROVIDER ADVISED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME, BUT WAS DUE TO THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8589236 ↗
• MalfunctionMar 1, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR ON THEIR DEVICE IS FLASHING AND A CALL SERVICE MESSAGE IS DISPLAYED. THE DEVICE ALSO LOGGED AN EVENT CODE THAT IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8382920 ↗