BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3924953 · Received June 24, 2014

    Report

    Report Number
    3003761017-2014-00093
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PATIENT WAS SWITCHED TO A BACKUP DRIVER WITHOUT ADVERSE IMPACT. 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 SYNCARDIA. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368104 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR