BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 15086228 · Received July 22, 2022

    Report

    Report Number
    1220908-2022-02605
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Report Date
    July 1, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL NETHERLANDS AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEWE OF THE DEVICE ACTIVITY LOGS SHOWED THAT THE USER PRESSED THE SHOCK BUTTON THREE TIMES BEFORE THE DEVICE COULD SUCCESSFULLY COMPLETE THE CHARGE. IT'S IMPORTANT TO NOTE THAT THE CUSTOMER WAS USING A NETECH DELTA 1600 ANALYER TO PERFORM THE TESTING ON THIS DEVICE. THIS IS NOT CONSIDERED TO BE A SUITABLE ANALYZER FOR TESTING OF ZOLL AED DEVICES. 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 FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102919 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown