BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    MDR report key: 6951260 · Received October 16, 2017

    Report

    Report Number
    3003761017-2017-00190
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 20, 2017
    Report Date
    September 20, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSED A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE COMPANION EXTERNAL BATTERY WILL NOT BE RETURNED TO SYNCARDIA FOR EVALUATION. TRANSPORTATION REGULATIONS DO NOT ALLOW BATTERIES WITH A CHARGE OVER 30% TO BE SHIPPED VIA AIR. SINCE THE BATTERY IS NOT RECOGNIZED BY THE COMPANION 2 DRIVER, IT CANNOT BE DISCHARGED FOR SHIPPING. THE BATTERY WILL BE DISPOSED ACCORDING TO EUROPEAN REGULATIONS. 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. (B)(4).

    Description of Event or Problem · 1

    THIS COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION EXTERNAL BATTERY WAS NOT RECOGNIZED BY THE COMPANION 2 DRIVER WHEN INSERTED. THE CUSTOMER ALSO REPORTED THAT THE BATTERY FUEL GAUGE INDICATED IT HAD A FULL CHARGE. THE CUSTOMER ALSO REPORTED THAT THE BATTERY CONNECTOR IS PUSHED BACK INTO THE HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731055 SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK BATTERY PACK LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1