BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 2954261 · Received January 7, 2013

    Report

    Report Number
    3003761017-2013-00006
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 7, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A SOUND HE DESCRIBED AS "LIKE SOMETHING LOOSE INSIDE THE DRIVER." AN ALARM SOUNDED, AND A "SINGLE COMPRESSOR MALFUNCTION" ERROR WAS DISPLAYED. THE PT WAS SWITCHED TO A BACKUP DRIVER WITHOUT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE IT DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVAL, AND THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7970 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR