BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM ONBOARD BATTERY

    MDR report key: 4231821 · Received October 15, 2014

    Report

    Report Number
    3003761017-2014-00197
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A TEMPERATURE ALARM WHILE USING SIX FREEDOM ONBOARD BATTERIES. THIS IS MFR REPORT 3 OF 6. SEE MFR REPORT #3003761017-2014-00195,00196,00198,00199, AND 00200. THE CUSTOMER REPORTED THAT THE PATIENT WAS GIVEN A NEW ONBOARD BATTERY AND IT WAS REPLACED WITHOUT ADVERSE PATIENT IMPACT. THE FREEDOM DRIVER CONTINUED TO FUNCTION AS INTENDED. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DOES NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. IN ADDITION, THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF EXTERNAL WALL POWER. THE FREEDOM ONBOARD BATTERY 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
    652674 FREEDOM ONBOARD BATTERY BATTERY LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR