BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 3203339 · Received July 2, 2013

    Report

    Report Number
    3203339
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 2, 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

    CONTROLLER FELL OFF BED WHILE TURNING PATIENT AND BECAME DISCONNECTED FOR 2 MINUTES. THE CONTROLLER WAS THEN RE-CONNECTED. THE PATIENT WAS STABLE THROUGHOUT THIS EVENT WITHOUT HEMODYNAMIC COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300940 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1