BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PLUS

    MDR report key: 3955283 · Received July 18, 2014

    Report

    Report Number
    1220908-2014-01861
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 14, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP. HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE RESPONDING TO A DROWNING VICTIM THE DEVICE RETURNED A "SHOCK ADVISED" DETERMINATION; THEN PROMPTED A "CHANGE BATTERIES" MESSAGE AND FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422098 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death