BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 10883725 · Received November 23, 2020

    Report

    Report Number
    1220908-2020-03751
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Report Date
    November 5, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    04560233596016
    PMA / PMN Number
    K011541/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUTOMER'S REPORT WAS ATTRIBUTED TO FLUID INGRESS. OUR EVALUATION FOUND INTERNAL FLUID DAMAGE. DUE TO THE OBSERVED CONDITION OF THE DEVICE, THE DEVICE WAS DEEMED COMPROMISED AND CANNOT BE REPAIRED. THE DEVICE WAS SCRAPPED. 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. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350193 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA 04560233596016

    Patients

    Seq Age Sex Outcome Treatment
    1