BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 3222919 · Received July 12, 2013

    Report

    Report Number
    3222919
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    February 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALARM ON CONTROLLER SCREEN SHOWED VAD STOPPED FOR 33 SEC. HISTORY SHOWED NO ASSOC. PWR OR FLOW DECREASE. CONTROLLER ACCIDENTALLY DROPPED, HITTING FLOOR WITH NO ALARMS. CONTROLLER CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323906 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1