BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 274920 · Received April 17, 2000

    Report

    Report Number
    2916596-2000-00011
    Event Type
    Malfunction
    Date Received
    April 17, 2000
    Date of Event
    May 23, 1997
    Report Date
    May 23, 1997
    Manufacturer
    THORATEC LABORATORIES, CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WITH LEFT AND RIGHT VENTRICULAR ASSIST DEVICES WAS BEING PREPARED TO BE TRANSFERRED FROM THE OPERATING ROOM AFTER IMPLANT, WHEN THE BOTTOM MODULE OF THE DUAL DRIVE CONSOLE SWITCHED OFF AS SOON AS THE AC POWER SUPPLY WAS DISCONNECTED. THERE WAS NO EFFECT ON THE PT. THE PT WAS TRANSPORTED FROM THE OPERATING ROOM USING THE TOP MODULE OF THE DUALDRIVE CONSOLE OPERATE BOTH VENTRICULAR ASSIST DEVICE.

    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 49 YR