BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 3040517 · Received March 11, 2013

    Report

    Report Number
    3003761017-2013-00027
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE BACK UP CONTROLLER ON THE CSS CONSOLE EXHIBITED A RED LIGHT AND A HUMMING NOISE WHEN THE BATTERY TEST BUTTON WAS PUSHED. THE PATIENT WAS SWITCHED TO A BACKUP CSS CONSOLE WITHOUT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE CSS CONSOLE HAS A REDUNDANT, PRIMARY CONTROLLER. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARDIA, AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102573 CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 15

    Patients

    Seq Age Sex Outcome Treatment
    1