BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM ONBOARD BATTERY

    MDR report key: 6186730 · Received December 19, 2016

    Report

    Report Number
    3003761017-2016-00399
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM ONBOARD BATTERY WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE ONBOARD BATTERY REVEALED J1 CONNECTOR SEPARATION FROM THE BATTERY HOUSING, CONFIRMING THE CUSTOMER-REPORTED ISSUE. THE ROOT CAUSE FOR THE HOUSING WELD AND J1 CONNECTOR SEPARATION OBSERVED ON ONBOARD BATTERY S/N (B)(4) COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON THE INFORMATION PROVIDED IN THE CUSTOMER REPORT; HOWEVER, DAMAGE OF THIS NATURE IS MOST LIKELY CAUSED BY AN IMPACT SHOCK. 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 THE PATIENT BECAUSE THE REPORTED ISSUE WOULD NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. IN ADDITION, THE FREEDOM DRIVER IS EQUIPPED WITH MULTIPLE REDUNDANT POWER SOURCES (E.G., EXTERNAL POWER VIA AC POWER SUPPLY AND CAR CHARGER) AND PATIENTS ARE PROVIDED WITH SEVERAL FREEDOM ONBOARD BATTERIES. THE FREEDOM ONBOARD BATTERY WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT WHILE EXCHANGING BATTERIES, IT WAS NOTICED THAT THE PATIENT'S FREEDOM ONBOARD BATTERY CONNECTOR WAS DETACHED FROM THE PLASTIC HOUSING. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT WHILE EXCHANGING BATTERIES, IT WAS NOTICED THAT THE PATIENT'S FREEDOM ONBOARD BATTERY CONNECTOR WAS DETACHED FROM THE PLASTIC HOUSING. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836235 SYNCARDIA FREEDOM ONBOARD BATTERY BATTERY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR