BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 7139870 · Received December 21, 2017

    Report

    Report Number
    3003761017-2017-00263
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 14, 2017
    Report Date
    December 14, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE PATIENT DATA FILE WAS REVIEWED AND REVEALED TWO EMERGENCY BATTERY ERROR ALARMS. THE ROOT CAUSE OF THE CUSTOMER-REPORTED ALARM WAS DETERMINED TO BE A MALFUNCTION OF THE EMERGENCY BATTERY. THE ROOT CAUSE OF THE MALFUNCTIONING EMERGENCY BATTERY COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON THE INFORMATION PROVIDED; HOWEVER, STORING THE DRIVER WITHOUT BEING CONNECTED TO EXTERNAL (WALL) POWER CAN CAUSE THE EMERGENCY BATTERY TO DEPLETE, LEADING TO A CAPACITY MALFUNCTION. THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL (C2-900005) PROVIDES GUIDANCE ON DRIVER STORAGE REQUIREMENTS IN SECTION 12.10, WHICH STATES "ALWAYS STORE COMPANION 2 DRIVERS IN A HOSPITAL CART OR CADDY THAT IS CONNECTED TO EXTERNAL (WALL) POWER." 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 THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ERROR ALARM.

    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 AN EMERGENCY BATTERY ERROR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916260 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1