BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 2883458 · Received November 14, 2012

    Report

    Report Number
    3003761017-2012-00081
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PATIENT. A SYNCARDIA CLINICAL SUPPORT REPRESENTATIVE REPORTED THAT DURING A TRAINING SESSION AT (B)(4), HE OBSERVED THAT THE BATTERY TEST PUSHBUTTON ON THE ALARM PANEL OF THE CSS CONSOLE WAS MISSING AND WAS FOUND ON THE FLOOR. THE HOSPITAL STAFF DID NOT KNOW HOW THE BATTERY TEST PUSHBUTTON FELL OFF. THE CSS CONSOLE WAS RETURNED TO SYNCARDIA. THE BATTERY TEST PUSHBUTTON SWITCH WAS REPLACED, AND THE CSS CONSOLE PASSED THE CONSOLE TEST VALIDATION PROTOCOL. ALTHOUGH IT IS UNKNOWN HOW THE BATTERY TEST SWITCH PUSHBUTTON WAS DAMAGED, IT IS POSSIBLE THAT THE CONSOLE WAS PUSHED INTO A STATIONARY OBJECT, E.G., A DOOR OR WALL. THE DAMAGE TO THE SWITCH DID NOT EXPOSE ANY ELECTRICAL CURRENT TO THE CONSOLE CHASSIS, AND THERE WAS NO RISK OF SHOCK. THIS 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, THE FAILURE MODE WOULD NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 25

    Patients

    Seq Age Sex Outcome Treatment
    1