BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PLUS

    MDR report key: 1083264 · Received July 25, 2008

    Report

    Report Number
    1220908-2008-01570
    Event Type
    Death
    Date Received
    July 25, 2008
    Date of Event
    May 14, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS 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 ANALYZER THE HEART RHYTHM OF A MALE PT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED, HOWEVER, IT WAS NOT RELATED TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death