BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 298819 · Received September 27, 2000

    Report

    Report Number
    2916596-2000-00025
    Event Type
    Malfunction
    Date Received
    September 27, 2000
    Date of Event
    August 29, 2000
    Report Date
    September 27, 2000
    Manufacturer
    THORATEC LABORATORIES, CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PT WAS BEING SUPPORTED WITH A THORATEC VENTRICULAR ASSIST DEVICE (VAD), WHEN THE BIOMEDICAL ENGINEER NOTICED SMOKE EMERGING FROM THE LOWER FRONT PORTION OF THE DUAL DRIVE CONSOLE (DDC). THE PT WAS DISCONNECTED FROM THE DDC AND WAS SUPPORTED USING THE EMERGENCY HAND PUMP UNTIL CONNECTED TO A BACK UP DRIVER CONSOLE. THERE WAS NO REPORTED EFFECT ON THE PT. THE DUAL DRIVE CONSOLE WAS SHIPPED BACK TO THORATEC PLEASANTON FOR INVESTIGATION. INITIAL EXAMINATION OF THE DDC SHOWED THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) HAS MALFUNCTIONED. THORATEC IS IN THE PROCESS OF FURTHER INVESTIGATING THIS FAILURE. THE UPS HAS BEEN SENT TO THE VENDOR 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