BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 1220810 · Received October 30, 2008

    Report

    Report Number
    3003761017-2008-00031
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 29, 2008
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ELECTRICAL PLUG RECEPTACLE HAD BECOME DISLODGED FROM THE SIDE PANEL AND FELL INSIDE THE CSS CONSOLE, AND THEREFORE, THE CSS CONSOLE COULD NOT BE CONNECTED TO WALL POWER. THE PT WAS SWITCHED TO A BACKUP CSS CONSOLE. THERE WAS NO PT IMPACT. AFTER THE PT WAS SWITCHED TO THE BACKUP CSS CONSOLE, THE VAD COORDINATOR RETRIEVED THE ELECTRICAL PLUG RECEPTACLE FROM THE INSIDE OF THE CSS CONSOLE AND WAS ABLE TO SECURELY REATTACH IT TO THE SIDE PANEL WITH ONE SCREW AND NUT. HE WAS UNABLE TO LOCATE THE OTHER SCREW. SYNCARDIA HAS REQUESTED THAT THE CSS CONSOLE BE RETURNED FOR EVALUATION.

    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 7

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR