BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 13426663 · Received February 2, 2022

    Report

    Report Number
    1220908-2022-00262
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Report Date
    January 12, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946002152
    PMA / PMN Number
    K011541/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH HANDLING, POWER CYCLING, AND FULL FUNCTIONAL STRESS TESTING INCLUDING ON/OFF CURRENT TESTING, USING THE RETURNED BATTERIES AND ELECTRODE PADS, WITHOUT DUPLICATING THE REPORT. REVIEW OF THE DEVICE ACTIVITY LOGS DID NOT SHOW ANY EVIDENCE TO SUPPORT THE CUSTOMER'S REPORT THE DEVICE PROMPTED UNIT FAILED IN RESCUE MODE. THEREFORE, OUR INVESTIGATION FOR THIS REPORTED MALFUNCTION WAS UNSUBSTANTIATED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    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
    1872418 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA 00847946002152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown