BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE 9VAD) SYSTEM

    MDR report key: 590987 · Received June 9, 2004

    Report

    Report Number
    2916596-2004-00068
    Event Type
    Malfunction
    Date Received
    June 9, 2004
    Date of Event
    May 14, 2004
    Report Date
    May 17, 2004
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, A DUAL DRIVE CONSOLE (DDC) SUPPORTING A BIVENTRICULAR ASSIST DEVICE PATIENT WAS UNPLUGGED TO TRANSFER THE PT FROM THE OR TO THE ICU AND BOTH MODULES ON DDC SHUT DOWN. THE PT WAS HAND-PUMPED TO THE ICU UNIT, THE DDC WAS PLUGGED BACK INTO THE ACPOWER AND RESUMED NORMAL PUMPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE 9VAD) SYSTEM VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention