BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 275503 · Received April 25, 2000

    Report

    Report Number
    2916596-2000-00013
    Event Type
    Malfunction
    Date Received
    April 25, 2000
    Date of Event
    November 12, 1997
    Report Date
    November 12, 1997
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PT TRANSPORT, THE CONTROL PANEL OF THE DUAL DRIVE CONSOLE (DDC) LOCKED UP AND THE VENTRICULAR ASSIST DEVICE (VAD) STOPPED PUMPING AFTER THE CONSOLE WAS PUSHED OVER A BUMP. THE PT WAS SWITCHED TO A BACK-UP DRIVER WITHOUT INCIDENT. THE DEVICE WAS EVALUATED ON-SITE BY A THORACTEC SERVICE TECHNICIAN. THE FAILURE COULD NOT BE DUPLICATED AND THE DEVICE MET ALL SPECIFICATIONS. THEREFORE, THE CASE OF EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE, DUAL DRIVE CONSOLE DSQ THORATEC LABORATORIES CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR