BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 289664 · Received August 9, 2000

    Report

    Report Number
    2916596-2000-00023
    Event Type
    Malfunction
    Date Received
    August 9, 2000
    Date of Event
    July 9, 2000
    Report Date
    July 11, 2000
    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

    WHEN THE DUAL DRIVE CONSOLE (DDC) WAS SWITCHED FROM AC TO BATTERY POWER, THE BOTTOM MODULE STOPPED FUNCTIONING. THE DDC WAS RECONNECTED TO AC POWER, THE LIGHTS ON THE FRONT PANEL OF THE BOTTOM MODULE CAME ON, BUT THE TOUCH PAD KEYBOARD WAS INOPERABLE. THE PT WAS SWITCHED TO A BACK-UP DRIVER. THERE WAS NO REPORTED EFFECT ON THE PT. THE UNIT WAS INITIALLY INVESTIGATED AND FAILURE VERIFIED AT THE SITE. THE 6VDC BATTERY IN THE BOTTOM MODULE OF THE DDC WAS REPLACED WHICH CORRECTED THE PROBLEM. THE FAULTY BATTERY WAS RETURNED TO THORATEC EUROPE, AND VISUAL EXAMINATION SHOWED FLUID LEAKAGE FROM THE BATTERY. THE BATTERY WILL BE RETURNED TO THORATEC'S MFG FACILITY IN CA, FOR FURTHER EVALUATION. ANY NECESSARY CORRECTIVE ACTION WILL BE DETERMINED UPON COMPLETION OF THE FAILURE INVESTIGATION.

    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 Required Intervention