BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3850959 · Received March 25, 2014

    Report

    Report Number
    3003761017-2014-00045
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 21, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS COMPANION 2 DRIVER WAS NOT IN USE BY A PT. THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER WAS EXHIBITING AN "EMERGENCY BATTERY ERROR" ALARM FOR SEVERAL DAYS WHILE IN STOCK AT THE HOSPITAL. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE 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. THE COMPANION 2 DRIVER HAS REDUNDANT, ALTERNATE POWER SOURCES OF EXTERNAL BATTERIES AND WALL POWER. 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
    173995 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1