BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 273084 · Received April 7, 2000

    Report

    Report Number
    2916596-2000-00007
    Event Type
    Malfunction
    Date Received
    April 7, 2000
    Date of Event
    February 7, 1996
    Report Date
    February 7, 1996
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TOP MODULE OF THE DUAL DRIVE CONSOLE SHUT DOWN WHEN UNPLUGGED FROM AC POWER. THE PT WAS SWITCHED TO A BACK-UP DRIVER. THERE WAS NO REPORTED EFFECT ON THE PT.

    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 UNKNOWN