BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3032085 · Received March 6, 2013

    Report

    Report Number
    3003761017-2013-00028
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 5, 2013
    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 SHE WAS UNABLE TO MOVE OR CLOSE THE "EXTENDED DATA" SCREEN ON THE COMPANION 2 TOUCH SCREEN. SHE ALSO REPORTED THAT SHE WAS UNABLE TO ACCESS THE MENU OR MAKE CHANGES. ALL DIAGNOSTIC INFO CONTINUED TO UPDATE. THE PT WAS SWITCHED TO A BACKUP DRIVER W/O IMPACT. AFTER THE PT WAS SWITCHED TO A BACKUP DRIVER, THE COMPANION 2 DRIVER WAS TURNED OFF AND TURNED ON, AND FULL FUNCTION OF THE TOUCHSCREEN WAS RESTORED. THEN THE COMPANION 2 DRIVER PASSED AN INITIAL SYSTEM CHECK. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE IT DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. AN INVESTIGATION WILL BE CONDUCTING BY SYNCARDIA, AND THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96543 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1