BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 739336 · Received July 12, 2006

    Report

    Report Number
    3003761017-2006-00026
    Event Type
    Malfunction
    Date Received
    July 12, 2006
    Date of Event
    January 29, 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

    Additional Manufacturer Narrative · 1

    AN ENTRY DATED 2005 IN THE CONSOLE SERVICING RECORDS FOR CONSOLE STATED "AFTER CALIBRATION OF BOTH OF THE CONTROL MODULES DISPLAY SHOWS 'CONTROL VALVE HAS A LEAK..'" THE ACTIVITY CHART IN THE SERVICING RECORD FOR THE DATE STATED "PRESSURE SENSORS (FLOW AND VENTRICLE PRESSURE CONTROL) CHECKED AND CALIBRATED. PROBLEM STILL EXISTING. CONTROL MODULE FROM ANOTHER CONSOLE USED, AFTER CALIBRATION SAME ERROR ERROR MESSAGE 'CONTROL VALVE HAS LEAK.' CONSOLE PUT OUT OF ACTION." FOLLOWING COMPLETION OF THE REPAIR ACTIVITIES, THE SERVICE REP CONDUCTED A SUCCESSFUL CONSOLE CHECKOUT PROCEDURE ABOUT 10 DAYS LATER AND THE CONSOLE WAS RETURNED TO THE CUSTOMER FOR USE. THE REVIEW OF THE SERVICE RECORDS AND COMPLAINTS FOR THIS CONSOLE INDICATED NO RECURRENCE OF THIS ALLEGED MALFUNCION. SYNCARDIA HAS BEEN UNABLE TO OBTAIN ANY ADDTIONAL INFO REGARDING THIS EVENT. A REVIEW OF COMPLAINT AND SERVICE RECORDS FROM Q4 2004 THROUGH 5/2006 DID NOT INDICATE A TREND OR OTHER PATTERN FOR THE REPORTED MALFUNCTION. SYNCARDIA IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    ON 6/16/06, 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 OUR INTERNATIONAL AFFILIATE WHICH WERE TRANSLATED FROM GERMAN TO ENGLISH.

    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 *