BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED3

    MDR report key: 15894253 · Received December 1, 2022

    Report

    Report Number
    1220908-2022-04625
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS ATTRIBUTED TO FLUID INGRESS. OUR EVALUATION FOUND INTERNAL FLUID DAMAGE. THE MAIN BOARD WAS SCRAPPED AND REPLACED TO REMEDY THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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
    1741292 AED3 DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown