BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 739349 · Received July 12, 2006

    Report

    Report Number
    3003761017-2006-00018
    Event Type
    Malfunction
    Date Received
    July 12, 2006
    Date of Event
    July 8, 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 16 JUNE 2006, 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 LOCATED IN ANOTHER COUNTRY, WHICH WERE TRANSLATED FROM GERMAN INTO ENGLISH. AN ENTRY DATED 2005 IN THE CONSOLE SERVICING RECORDS FOR CONSOLE STATED "VACUUM CONTROLLER DEFUNCT AND CONTROL VALVE UNTIGHT." THE ACTIVITY CHART IN THE SERVICING RECORDS STATED "CONTROLLER FOR VACUUM REPAIRED AND CONTROL PRESSURE ADJUSTED. FUNCTIONAL TEST ACCORDING TO MFR'S SPECS CONDUCTED. DEVICE MADE READY FOR SHIPMENT AND SHIPPED OFF VIA SHIPPING COMPANY." FOLLOWING COMPLETION OF THE REPAIR ACTIVITIES, THE SERVICE REP CONDUCTED A SUCCESSFUL CONSOLE CHECKOUT PROCEDURE IN 2005 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 MALFUNCTION. SYNCARDIA HAS BEEN UNABLE TO OBTAIN ANY ADD'L INFO REGARDING THIS EVENT. A REVIEW OF COMPLAINT AND SERVICE RECORDS FROM Q4 2004 THROUGH MAY 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 500046R

    Patients

    Seq Age Sex Outcome Treatment
    1 *