BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 276103 · Received April 27, 2000

    Report

    Report Number
    2916596-2000-00016
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SET UP OF THE DUAL DRIVE CONSOLE PRIOR TO VENTILATOR ASSIST DEVICE IMPLANTATION, THE COMPRESSORS WERE SWITCHED ON, BUT NO PRESSURE COULD BE OBTAINED FROM THE COMPRESSOR THAT SUPPLIES PRESSURE TO THE BOTTOM MODULE. THE DDC WAS CONNECTED TO A PT AT THE TIME OF THE FAILURE. THE PROBLEM WAS ISOLATED TO THE COMPRESSOR THAT SUPPLIES PRESSURE TO THE BOTTOM MODULE OF THE DDC. EVAL SHOWED THAT THE COMPRESSOR FUNCTIONED INTERMITTENTLY. THE COMPRESSOR WAS SENT TO THE VENDOR FOR EVAL WHO TRACED MALFUNCTION TO MISALIGNMENT OF THE PISTON IN THE CYLINDER. SINCE THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE, NO CORRECTIVE ACTION WAS IMPLEMENTED.

    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 *