BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3180211 · Received June 4, 2013

    Report

    Report Number
    3003761017-2013-00062
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS COMPANION 2 DRIVER WAS NOT SUPPORTING A PT. THE CUSTOMER REPORTED THAT THE DISPLAY SCREEN ON THE COMPANION 2 DRIVER DID NOT FUNCTION. WHEN THE DRIVER WAS PLACED IN A HOSPITAL CART, THE MONITORING SCREEN ON THE HOSPITAL CART FUNCTIONED PROPERLY BUT THE COMPANION 2 DISPLAY SCREEN REMAINED BLANK. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PT. IN ADDITION, THE REPORTED ISSUE WOULD 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 A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247613 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1