BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 9130690 · Received September 27, 2019

    Report

    Report Number
    3003761017-2019-00276
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 27, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EMERGENCY BATTERY ERROR ALARM WAS CONFIRMED DURING THE PATIENT DATA FILE REVIEW. DURING THE BATTERY EVALUATION, A PACK UNDER VOLTAGE (PUV) SAFETY FLAG WAS OBSERVED. HOWEVER, NO PERMANENT FAULTS WERE RECORDED FOR THE EMERGENCY BATTERY. THIS IS AN INDICATION THAT THE EMERGENCY BATTERY WAS DEPLETED AND MAY HAVE NEEDED LONGER THAN THE TYPICAL ONE HOUR TO FULLY CHARGE. THE EMERGENCY BATTERY WAS ALLOWED TO CHARGE FOR APPROXIMATELY 24 HOURS. AFTER CHARGING, THE BATTERY WAS RE-EVALUATED AND FOUND TO BE FULLY CHARGED WITH NO NEW EMERGENCY BATTERY ERROR ALARMS OBSERVED. THIS INDICATED THAT AFTER CHARGING, THE BATTERY WAS FUNCTIONING AS INTENDED. THE LIKELY CAUSE OF THE DEPLETED EMERGENCY BATTERY WHICH TRIGGERED THE EMERGENCY BATTERY ERROR ALARM WAS LACK OF SHORE POWER DURING THE TRANSPORT AND SHIPPING PROCESS. 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

    WHILE PERFORMING A ROUTINE EVALUATION, A SYNCARDIA TECHNICIAN REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ERROR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922970 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1