BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 KIT, AUTO, US ENG/ESP LA

    MDR report key: 22161324 · Received June 6, 2025

    Report

    Report Number
    2112020-2025-00390
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Report Date
    May 16, 2025
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394021192
    PMA / PMN Number
    P160033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY ZOLL MEDICAL CORPORATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO A VARIABLE RESISTOR ON THE MONITOR BOARD. THE DEVICE WAS SCRAPPED. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION THE DEVICE PROMPTED A "SELF TEST FAILURE FOR P/S V OUT OF RANGE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. -LOG REVIEW ITEM FOUND ON 16MAY25 BY SLC 30D2B (042422 R).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461980 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