BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 5001345 · Received August 11, 2015

    Report

    Report Number
    3003761017-2015-00255
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    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 EXHIBITED AN EMERGENCY BATTERY ALARM. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT, 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 EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525623 SYNCARDIA COMPANION 2 DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR