BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 2212852 · Received July 12, 2011

    Report

    Report Number
    3003761017-2011-00017
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT ON A PT. CUSTOMER IN (B)(6) REPORTED THAT DURING PERFORMANCE OF A ROUTINE CONSOLE TEST VALIDATION PROTOCOL, THE HARD DISK DRIVE IN THE CSS CONSOLE MONITORING COMPUTER DIDN'T START. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PT, BECAUSE IT WAS OBSERVED DURING A ROUTINE SYSTEM CHECKOUT AND THE CSS CONSOLE WAS NOT SUPPORTING A PT. IN ADDITION, THE ALLEGED FAILURE MODE DOES NOT NEGATE THE CSS CONSOLE'S ABILITY TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE COMPUTER IS A MONITORING DEVICE ONLY AND DOES NOT CONTROL CSS CONSOLE FUNCTIONALLY. SYNCARDIA SENT A REPLACEMENT HARD DISK DRIVE TO THE CUSTOMER. CONFIRMATION THAT REPLACEMENT OF THE HARD DISK DRIVE CORRECTED THE ISSUE AND THAT THE CSS CONSOLE PERFORMS AS INTENDED WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    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 35

    Patients

    Seq Age Sex Outcome Treatment
    1