BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 9345062 · Received November 19, 2019

    Report

    Report Number
    3003761017-2019-00332
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    November 1, 2019
    Report Date
    December 5, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INITIAL INCOMING TESTING, THE DRIVER DISPLAY WAS FROZEN AT THE AMBULATORY SCREEN SIMILAR TO THE CUSTOMER-REPORTED ISSUE. IN ORDER TO PERFORM FUNCTIONAL TESTING, THE DRIVER WAS CONNECTED TO A HOSPITAL CART AND THROUGH THE HOSPITAL CART SETUP SCREEN, THE DRIVER TOUCH SCREEN WAS SET FOR CALIBRATION. AFTER THE SUCCESSFUL CALIBRATION OF THE DRIVER TOUCH SCREEN, THE DRIVER'S TOUCH SCREEN RETURNED TO NORMAL OPERATION. TEN POWER CYCLES WERE THEN PERFORMED WHERE THE DRIVER TOUCH SCREEN SUCCESSFULLY CHANGED MODES, PATIENT SETTINGS, AND MENU MODES WITH NO ANOMALIES OBSERVED. C2-900005, SYNCARDIA COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL, EXPLAINS BOTH THE DRIVER SCREEN AND HOSPITAL CART SCREEN CALIBRATION PROCESSES (SECTION 8.1.10), AND WHAT TO DO IF THE DRIVER TOUCH SCREEN IS NON-RESPONSIVE (SECTION 4.13). USING THE STEPS AS DESCRIBED IN SECTION 8.1.10 OF C2-900005, THE RETURNED DRIVER WAS SUCCESSFULLY CALIBRATED ON USING A HOSPITAL CART DURING THIS INVESTIGATION. THERE WAS NO EVIDENCE OF A DEVICE A MALFUNCTION. 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 5049 FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE COMPANION 2 DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE TOUCH SCREEN ON THE COMPANION 2 DRIVER WAS NOT RESPONDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140008 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1