BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 4250445 · Received November 7, 2014

    Report

    Report Number
    3003761017-2014-00254
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A "SINGLE COMPRESSOR MALFUNCTION" ALARM WHILE SUPPORTING A PT. THE PT REPORTED FEELING "LIGHTHEADED" FOR A FEW SECONDS. THE PT WAS SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE IT DOES NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719299 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR