BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3040553 · Received March 11, 2013

    Report

    Report Number
    3003761017-2013-00032
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 22, 2012
    Report Date
    March 8, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER WAS CONNECTED TO WALL POWER FOR OVER 16 HOURS, BUT THE INTERNAL EMERGENCY BATTERY COULD NOT BE CHARGED. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT, BECAUSE THE ISSUE WAS OBSERVED WHEN THE DRIVER WAS NOT SUPPORTING A PATIENT. 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
    102457 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1