BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 9411020 · Received December 4, 2019

    Report

    Report Number
    3003761017-2019-00363
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 20, 2019
    Report Date
    January 3, 2020
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EMERGENCY BATTERY ERROR ALARM WAS CONFIRMED DURING REVIEW OF THE PATIENT FILE REVIEW. DURING THE BATTERY EVALUATION, A CELL UNDER VOLTAGE SAFETY FLAG (CUV) AND A PACK UNDER VOLTAGE SAFETY FLAG (PUV) WERE OBSERVED. THESE FIRMWARE SAFETY FLAGS INDICATED THAT THE BATTERY CELLS WENT BELOW THE ALLOWED VOLTAGE LEVEL WHICH OCCURS DURING A "FULL-DISCHARGE" EVENT. THE ROOT CAUSE OF THE REPORTED ALARM WAS A DEPLETION OF THE EMERGENCY BATTERY DURING AN UNDERCHARGE EVENT WHICH RESULTED IN AN UNRECOVERABLE PERMANENT FAULT. 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 5089 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 2 DRIVER WAS NOT SUPPORTING A PATIENT. 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
    1206865 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1