BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    MDR report key: 9313092 · Received November 12, 2019

    Report

    Report Number
    3003761017-2019-00326
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 30, 2019
    Report Date
    September 17, 2020
    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

    DURING INVESTIGATION TESTING, THE BATTERY ISSUE WAS REPLICATED AS THE DISCHARGE TIME WAS OUTSIDE THE TESTING ACCEPTANCE CRITERIA. THE ROOT CAUSE WAS DETERMINED TO BE THE PACK UNDER VOLTAGE (PUV) PROTECTION CIRCUIT CUTTING OUTPUT CURRENT FROM THE BATTERY BEFORE THE CELLS WERE ACTUALLY AT RISK OF BEING 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. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES 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 BE 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 EXTERNAL BATTERY DISCHARGE TIME WAS OUTSIDE THE TESTING ACCEPTANCE CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102632 SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK BATTERY PACK LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1