BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3982807 · Received June 13, 2014

    Report

    Report Number
    3003761017-2014-00089
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A "SYSTEM MALFUNCTION" ALARM WHILE SUPPORTING A PT. THE PT WAS SWITCHED TO THE BACKUP DRIVER WITHOUT ADVERSE IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE IT DID NOT PREVENT THE DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351298 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR