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LIFEPAK® CR Plus and LIFEPAK Express defibrillators 99427Recalls & reported problems

Physio-Control, Inc. · ASSY,LP EXPRESS, SEMI, ENG,AHA2005 · Class 3

All models of LIFEPAK CR Plus and LIFEPAK Express defibrillators (25)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074734453), received between Jun 4, 2018 and Nov 9, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (2 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

Device problems

  • Failure to Power Up2
  • Power Problem1

Patient problems

  • No Patient Involvement3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 9, 2018Failure to Power Up; Failure to Power Up

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE WRENCH ICON PRESENT ON ITS READINESS DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) WERE PRESENT ON ITS READINESS DISPLAY AND THAT IT WOULD NOT POWER ON WHEN PROMPTED.

    Patient problems: No Patient Involvement

    MAUDE report 8057207 ↗
  • MalfunctionSep 14, 2018Power Problem; Power Problem

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 7878815 ↗
  • MalfunctionJun 4, 2018Failure to Power Up; Failure to Power Up

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT POWER ON WHEN PROMPTED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 7567133 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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