BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 KIT,AUTO,BG-INTL EN

    MDR report key: 23131485 · Received September 24, 2025

    Report

    Report Number
    2112020-2025-00599
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Report Date
    September 3, 2025
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CHANGES MADE TO B5 TO REFLECT THIS WAS A DUPLICATE REPORT. THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 2112020-2025-00616.

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 2112020-2025-00616.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641747 POWERHEART G5 KIT,AUTO,BG-INTL EN AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5A-47A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown