LIFEPAK® 12 defibrillator/monitor 99400 (REF 99400-002496)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074269535), received between Dec 19, 2018 and Jun 24, 2019 — classified as 3 malfunctions.

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

• MalfunctionJun 24, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WILL NOT POWER ON USING AC POWER OR BATTERIES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8729622 ↗
• MalfunctionJan 31, 2019Charging Problem; Charging Problem

  THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT CHARGE TO SHOCK WHEN CONNECTED TO THE AC POWER ADAPTER. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8293400 ↗
• MalfunctionDec 19, 2018Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DEVICE DOES NOT DELIVER DEFIBRILLATION ENERGY DURING TESTING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8179480 ↗