BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 717398 · Received August 29, 2005

    Report

    Report Number
    1220908-2005-01935
    Event Type
    Malfunction
    Date Received
    August 29, 2005
    Report Date
    August 4, 2005
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE DEVICE SHUTS DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS NAY PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other