BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 1021886 · Received March 28, 2008

    Report

    Report Number
    3003761017-2008-00012
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 27, 2008
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CONSOLE WAS NOT ON A PT. CUSTOMER REPORTED THAT DURING ROUTINE CONSOLE CHECKOUT, THE CSS CONSOLE WOULD NOT PASS CALIBRATION. A SYNCARDIA CLINICAL SUPPORT REP EXAMINED THE CONSOLE AND FOUND THAT THE ZERO SETTING IN THE CALIBRATION OF THE FLOW SENSORS WAS ABOVE THE BASELINE. HE ADJUSTED THE ZERO SET POINT OF THE TRANSDUCER, AND THE CONSOLE SUCCESSFULLY PASSED THE CONSOLE CALIBRATION PROTOCOL. THIS ALLEGED FAILURE MODE POSES NO RISK TO A PT BECAUSE IT OCCURRED DURING ROUTING CONSOLE CHECKOUT AND WAS NOT ON A PT. THE ALLEGED FAILURE MODE IS A FALSE ALARM AND DOES NOT AFFECT THE FUNCTIONALITY OF THE CONSOLE. THE ISSUE WAS OBSERVED DURING CONSOLE CHECKOUT AND WAS CORRECTED ON SITE. THE CSS CONSOLE HAS ALARMS TO DETECT THIS ISSUE IF IT WERE TO RECUR. SYNCARDIA HAS COMPLETED ITS EVAL OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE DSQ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 14

    Patients

    Seq Age Sex Outcome Treatment
    1