BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 8768781 · Received July 8, 2019

    Report

    Report Number
    3003761017-2019-00214
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 23, 2019
    Report Date
    July 11, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE EMERGENCY BATTERY ERROR ALARM AS REPORTED WAS CONFIRMED DURING PATIENT FILE REVIEW. DURING BATTERY EVALUATION A CELL UNDER VOLTAGE (CUV) FLAG AND A PACK UNDER VOLTAGE (PUV) FLAG WERE OBSERVED, HOWEVER NO PERMANENT FAULTS WERE RECORDED. THIS IS AN INDICATION THAT THE EMERGENCY BATTERY WAS DEPLETED AND MAY NEED LONGER THAN THE USUAL ONE HOUR TO FULLY CHARGE. THE EMERGENCY BATTERY WAS ALLOWED TO CHARGE FOR APPROXIMATELY 48 HOURS. AFTER CHARGING, THE BATTERY WAS RE-EVALUATED AND FOUND TO HAVE FULLY CHARGED, THUS CONFIRMING THAT THE BATTERY IS FUNCTIONING AS INTENDED. SINCE THE DRIVER WAS RETURNED WITH THE KEY SWITCH IN THE "ON" POSITION IT IS LIKELY THAT THE DRIVER OPERATED FOR AN EXTENDED PERIOD OF TIME POWERED BY THE EMERGENCY BATTERY, CAUSING IT TO BECOME DEPLETED. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. CE 4864 FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER IS BEING EVALUATED BY SYNCARDIA. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    WHILE PERFORMING A ROUTINE EVALUATION, A SYNCARDIA TECHNICIAN REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ERROR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562756 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1