BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 3821365 · Received April 28, 2014

    Report

    Report Number
    3003761017-2014-00057
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PT. THE CUSTOMER REPORTED THAT WHEN THE BATTERY TEST BUTTON WAS PRESSED ON THE PRIMARY CONTROLLER OF THE CSS CONSOLE, THE CONTROLLER LIGHT TURNED RED. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE IT WAS OBSERVED WHEN THE CSS CONSOLE WAS NOT SUPPORTING A PT. IN ADDITION, THIS ALLEGED FAILURE MODE WOULD NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE CSS CONSOLE HAS A REDUNDANT, PRIMARY CONTROLLER. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARDIA. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254448 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 30

    Patients

    Seq Age Sex Outcome Treatment
    1