BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 KIT, AUTO, US ENG/ESP LA

    MDR report key: 23758918 · Received December 9, 2025

    Report

    Report Number
    2112020-2025-00772
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Report Date
    November 20, 2025
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394021192
    PMA / PMN Number
    P160033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING DAILY/WEEKLY/MONTHLY TESTING, "FAST" TESTING, AND INTERNAL INSPECTION WITHOUT DUPLICATING THE REPORT. THE MAIN BOARD AND CAPACITORS WILL BE REPLACED AS A PRECAUTION. THE DEVICE WILL BE RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE LOGS MAKES IT CLEAR THE DEVICE PRESENTED AN ERROR IN JULY WHERE THE END RESULT WAS THAT THE DEVICE CODE INDICATOR WAS RED AND BEEPING. 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. WE CAN IDENTIFY FROM THE LOG THAT THIS DEVICE APPEARS TO HAVE BEEN LEFT IDLE IN A NON-USABLE STATE FOR A LEAST 4 MONTHS. THIS REPORT HAS BEEN ATTRIBUTTED TO AN UNADDRESSED ADVISORY MESSAGE. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED N "HV CHARGER TEST CAPACITOR NOT HOLDING CHARGE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2721715 POWERHEART G5 KIT, AUTO, US ENG/ESP LA AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5A-80A NA 00812394021192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown