BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3012995 · Received February 26, 2013

    Report

    Report Number
    3003761017-2013-00025
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 25, 2013
    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

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER DID NOT RECOGNIZE WALL AIR AND ALWAYS RAN ON THE COMPRESSOR. THE CUSTOMER CHECKED THE AIR SUPPLY AND AIR HOSE AND DID NOT FIND AN ISSUE. THE PATIENT WAS SWITCHED TO A BACKUP DRIVER WITHOUT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT, BECAUSE IT DOES NOT HAVE ANY EFFECT ON THE COMPANION 2 DRIVER¿S ABILITY TO PERFORM ITS LIFE SUSTAINING FUNCTIONS. SYNCARDIA HAS REQUESTED THAT THE COMPANION 2 DRIVER BE RETURNED 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
    83188 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1