BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3820601 · Received May 7, 2014

    Report

    Report Number
    3003761017-2014-00065
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 6, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPRESSORS ON THE COMPANION 2 DRIVER WOULD TURN ON WHEN THE DRIVER WAS CONNECTED TO HOSPITAL WALL AIR. THE CUSTOMER ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT AND THE PATIENT WAS STILL BEING SUPPORTED BY THE COMPANION 2 DRIVER. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DOES NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARIDA. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN THE SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276613 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR