BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 274499 · Received April 17, 2000

    Report

    Report Number
    2916596-2000-00010
    Event Type
    Malfunction
    Date Received
    April 17, 2000
    Date of Event
    May 10, 1997
    Report Date
    May 10, 1997
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DUAL DRIVE CONSOLE WAS BEING TESTED FOR PRE-OPERATIONAL USE, WHEN A POPPING NOISE WAS HEARD FROM THE UNINTERRUPTIBLE POWER SUPPLY, WHEN THE BOTTOM MODULE A COMPRESSORS WERE TURNED ON. THE UNIT WAS SWITCHED FROM AC TO BATTERY AND THEN BACK TO AC AGAIN WITH THE SAME RESULTS. THE BACK-UP CONSOLE WAS USED INSTEAD.

    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 NA