BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 6137929 · Received December 1, 2016

    Report

    Report Number
    3003761017-2016-00373
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE DRIVER'S INTERNAL COMPONENTS REVEALED THAT THE FLAT-HEAD SCREWS CONNECTING THE COMPRESSOR MOTOR TO THE HOUSING WERE BACKED OUT, WHICH ALLOWED THE COMPRESSOR MOTOR TO PULL AWAY FROM THE HOUSING. THE ABNORMAL NOISE WAS REPRODUCED DURING TESTING, AND WAS ATTRIBUTED TO EXCESSIVE SHAKING OF THE COMPRESSOR. 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).

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT DURING TESTING, THE COMPRESSOR IN THE COMPANION 2 DRIVER WAS MUCH LOUDER THAN OTHER MACHINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790452 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1