BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3062594 · Received March 18, 2013

    Report

    Report Number
    3003761017-2013-00034
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 8, 2012
    Report Date
    March 9, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER'S AIR COMPRESSOR CYCLES ON EVENT WHEN THE DRIVER IS CONNECTED TO HOSPITAL WALL AIR. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER WAS SUPPORTING THE PATIENT AS EXPECTED, AND THE PATIENT IS STILL BEING SUPPORTED BY THIS COMPANION 2 DRIVER. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT, BECAUSE IT DOES NOT HAVE ANY EFFECT ON THE COMPANION 2 DRIVER'S ABILITY TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. 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
    112754 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR