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LIFEPAK® CR Plus and LIFEPAK Express defibrillators 80403 (REF 80403-000279)Recalls & reported problems

Physio-Control, Inc. · PACKAGE,LPCR PLUS,AUTO,ENGLISH,AHA2005, CANADA · 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873894262), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Analyze Signal” (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

Device problems

  • Failure to Analyze Signal1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 19, 2018Failure to Analyze Signal; Failure to Analyze Signal

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED A SERVICE INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL FOUND THAT THE IT DID NOT RECOGNIZE A SHOCKABLE RHYTHM. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY.

    Patient problems: No Patient Involvement

    MAUDE report 7444448 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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