BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 8685375 · Received June 10, 2019

    Report

    Report Number
    3003761017-2019-00178
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 22, 2019
    Report Date
    September 16, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    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 ISSUE WAS CONFIRMED VIA REVIEW OF THE DRIVER'S ALARM HISTORY WHICH REVEALED AN ALARM CODE PRODUCED BY THE NON-ENGAGEMENT OF THE PRIMARY MOTOR AND WAS REPRODUCED DURING INVESTIGATIONAL TESTING. THE ROOT CAUSE WAS DETERMINED TO BE A MALFUNCTION OF THE POTENTIOMETER (RV1) ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). 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 4817 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 FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE FREEDOM DRIVER 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 FREEDOM DRIVER MOMENTARILY STOPPED THEN RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478162 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1