BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 276052 · Received April 27, 2000

    Report

    Report Number
    2916596-2000-00015
    Event Type
    Malfunction
    Date Received
    April 27, 2000
    Date of Event
    February 26, 1999
    Report Date
    February 26, 1999
    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 WAS DISCONNECTED FROM AC POWER, THE TOP MODULE STOPPED FUNCTIONING. THE PT WAS SWITCHED TO A BACK-UP CONSOLE WITH NO ADVERSE EFFECTS. THE UNIT WAS TESTED AT THE SITE AND A CIRCUIT BOARD WAS REPLACED BY A THROATEC SERVICE TECHNICIAN, WHICH CORRECTED THE PROBLEM. THE CIRCUIT BOARD WAS RETURNED TO THORATEC FOR FURTHER EVAL, BUT NO CAUSE OF FAILURE COULD BE DETERMINED. NO CORRECTIVE ACTION ACTION WAS IMPLANTED AS THE CAUSE OF FAILURE IS UNKNOWN.

    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