BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PLUS

    MDR report key: 1081201 · Received July 21, 2008

    Report

    Report Number
    1220908-2008-01668
    Event Type
    Death
    Date Received
    July 21, 2008
    Date of Event
    October 22, 2007
    Report Date
    July 15, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL COPR HAS NOT REC'D THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PT, THE DEVICE FAILED TO DETECT THE ATTACHED PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED, HOWEVER, IT WAS NOT ASSOCIATED WITH 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 40 YR Death