BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    MDR report key: 7439839 · Received April 18, 2018

    Report

    Report Number
    3003761017-2018-00118
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 3, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE COMPANION EXTERNAL BATTERY WAS NOT IN PATIENT USE WHEN THE ISSUE WAS OBSERVED. IN ADDITION, IT WOULD NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER HAS A REDUNDANT, ALTERNATE POWER SOURCE OF EXTERNAL WALL POWER. THE COMPANION EXTERNAL BATTERY WILL NOT BE RETURNED TO SYNCARDIA FOR EVALUATION. TRANSPORTATION REGULATIONS DO NOT ALLOW BATTERIES WITH A CHARGE OVER (B)(4)% TO BE SHIPPED VIA AIR. SINCE THE EXTERNAL BATTERY HAS A DISPLACED CONNECTION, IT CANNOT BE DISCHARGED FOR SHIPPING. THE EXTERNAL 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.

    Description of Event or Problem · 1

    THIS COMPANION EXTERNAL BATTERY WAS NOT IN PATIENT USE. THE SUPPLIER, A SYNCARDIA AUTHORIZED WAREHOUSE, REPORTED THAT THE CONNECTOR ON THE COMPANION EXTERNAL BATTERY WAS DISPLACED AND THE BATTERY COULD NOT BE CHARGED OR DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284671 SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK BATTERY PACK LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1