BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 2974631 · Received January 29, 2013

    Report

    Report Number
    3003761017-2013-00013
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 28, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT WHILE PERFORMING A ROUTING CONSOLE TEST VALIDATION PROTOCOL, THE MONITORING COMPUTER AND THE VACUUM WOULD NOT TURN ON. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT, BECAUSE THE ISSUE WAS OBSERVED WHEN THE CSS CONSOLE WAS NOT SUPPORTING A PATIENT. IN ADDITION, REPORTED ISSUE WOULD NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPUTER IS A MONITORING DEVICE ONLY AND DOES NOT CONTROL CSS CONSOLE FUNCTIONALITY, HAD THE CSS CONSOLE CAN PROVIDE ADEQUATE PNEUMATIC SUPPORT WITHOUT VACUUM. THE CSS CONSOLE WILL BE RETURNED TO SYNCARDIA FOR REVALUATION. THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39852 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 3

    Patients

    Seq Age Sex Outcome Treatment
    1