BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 739345 · Received July 12, 2006

    Report

    Report Number
    3003761017-2006-00027
    Event Type
    Malfunction
    Date Received
    July 12, 2006
    Date of Event
    December 23, 2005
    Report Date
    July 12, 2006
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON 7/16/06, SYNCARDIA SYSTEMS, INC. BECAME AWARE OF A POSSIBLE MALFUNCTION OF A CSS CONSOLE, AS A RESULT OF A REVIEW OF CONSOLE SERVICING RECORDS RECEIVED FROM SYNCARDIA'S SERVICE REP. AN ENTRY DATED FOR 2005, IN THE CONSOLE SERVICING RECORDS STATED, "DEVICE MAKES A HISSING SOUND IF ZV-SUPPLY IS DISENGAGED." THE ACTIVITY CHART IN THE SERVICING RECORDS STATED, "NONRETURN VALVE RENEWED. PRIMARY PRESSURE (HD) RENEWED. DEVICE CALIBRATED AND CHECKED." SYNCARDIA HAS BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFO REGARDING THIS EVENT. A REVIEW OF COMPLAINT AND SERVICE RECORDS FROM Q4 2004 THROUGH 2006 DID NOT INDICATE A TREND OR OTHER PATTERN FOR THE REPORTED MALFUNCTION. SYNCARDIA 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 2270201

    Patients

    Seq Age Sex Outcome Treatment
    1 *