BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PRO

    MDR report key: 3812571 · Received April 17, 2014

    Report

    Report Number
    1220908-2014-00933
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A CONSCIOUS MALE PATIENT, THE DEVICE SELF-CHARGED ENERGY INAPPROPRIATELY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236020 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK