BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 2954262 · Received January 7, 2013

    Report

    Report Number
    3003761017-2013-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 7, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER'S AIR COMPRESSORS DID NOT TURN OFF WHEN THE DRIVER WAS CONNECTED TO HOSPITAL WALL AIR, AND THE AIR ICON WAS STILL LIT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT, BECAUSE IT DOES NOT HAVE ANY EFFECT ON THE COMPANION 2 DRIVER'S ABILITY TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE PT IS STILL BEING SUPPORTED BY THIS COMPANION 2 DRIVER. 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
    6867 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR