BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 6151673 · Received December 7, 2016

    Report

    Report Number
    3003761017-2016-00386
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE PATIENT DATA FILE WAS REVIEWED AND NO COMPUTER MALFUNCTION ALARMS OR ANY OTHER RELEVANT ALARMS WERE OBSERVED. OBSERVATION RUN AND POWER CYCLE TESTING COULD NOT REPRODUCE THE CUSTOMER-REPORTED ISSUE. THE DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE 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. (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 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE COMPANION 2 DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION 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 COMPANION 2 DRIVER EXHIBITED A COMPUTER MALFUNCTION ALARM DURING START UP.

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A COMPUTER MALFUNCTION ALARM DURING START UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801460 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1