BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 4862199 · Received June 17, 2015

    Report

    Report Number
    1220908-2015-01539
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Report Date
    June 5, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MED CORP FOR EVAL. DURING DISASSEMBLY OF THE DEVICE TO DETERMINE ROOT CAUSE, THE TECHNICIAN OBSERVED DAMAGE CONSISTENT WITH MIS-HANDLING. ROOT CAUSE COULD NOT BE FIRMLY ESTABLISHED DUE TO THE OBSERVED DAMAGE. THE MAIN BOARD WAS REPLACED, THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392872 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA