BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 KIT, AUTO, UK

    MDR report key: 10508738 · Received September 9, 2020

    Report

    Report Number
    2112020-2020-00697
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    August 19, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORTS WERE OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING FULL FUNCTIONAL TESTING AND DWM SELF-TESTING WITHOUT DUPLICATING THE REPORTS. THE ERRORS WERE CLEARED FROM THE LOG. AN INTERNAL INSPECTION OF THE DEVICE FOUND FOREIGN SUBSTANCE ON THE MAIN BOARD. THE MAIN BOARD WAS REPLACED AND SCRAPPED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE AND FAILED THE POWER-ON UPGRADE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975518 POWERHEART G5 KIT, AUTO, UK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5A-02A NA

    Patients

    Seq Age Sex Outcome Treatment
    1