BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERHEART

    MDR report key: 369326 · Received December 27, 2001

    Report

    Report Number
    2030912-2001-00003
    Event Type
    Other
    Date Received
    December 27, 2001
    Date of Event
    November 27, 2001
    Report Date
    November 27, 2001
    Manufacturer
    CARDIAC SCIENCE INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH PARKINSON'S DISEASE CONNECTED TO A POWERHEART RECEIVED A SHOCK FROM THE DEVICE WHILE PATIENT WAS IN STABLE CONDITION. THE PATIENT WAS IN A GOOD CONDITION, AND SUBSEQUENTLY DISCONNECTED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58685 POWERHEART EXTERNAL CARDIO DEFIBRILLATOR LDD CARDIAC SCIENCE INC. 180-0002 10100107

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other