BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 SEMI AUTOMATIC AED

    MDR report key: 25116364 · Received May 7, 2026

    Report

    Report Number
    2112020-2026-00173
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Report Date
    April 15, 2026
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394021239
    PMA / PMN Number
    P160034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT BASED ON DEBUG AND FINAL TESTING, NO NEW EVIDENCE WAS FOUND POST THE QA NFF REVIEW. THE INVESTIGATION IS CLOSED AS OBSERVED IN DEVICE DATA - LATCHED. THE MAIN BOARD WAS REPLACED AS A PRECAUTION. EVALUATION OF THE MAIN BOARD DID NOT DUPLICATE THE ISSUE AT BOARD LEVEL TESTING. SENT BOARD TO SCRAP. IT IS IMPORTANT TO NOTE THAT THE DEVICE WILL COMMUNICATE TO THE USER THAT IT IS NOT RESCUE READY BY PROVIDING AN AUDITORY BEEP EVERY 30 SECONDS AND DISPLAYING A RED RESCUE READY (NVI) INDICATOR. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "SELF TEST FAILURE FOR Z SAMPLE < THRESHOLD" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55017 POWERHEART G5 SEMI AUTOMATIC AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5S-01A NA 00812394021239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown