BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 3213936 · Received July 9, 2013

    Report

    Report Number
    3007042319-2013-00116
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    February 23, 2013
    Report Date
    December 19, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314583 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650 BAT003638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."