BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM BATTERY CHARGER

    MDR report key: 15631888 · Received October 19, 2022

    Report

    Report Number
    3003761017-2022-00111
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 27, 2022
    Report Date
    July 24, 2024
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FREEDOM BATTERY CHARGER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL (3 OF 3).

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT FREEDOM BATTERY CHARGER S/N (B)(6) PASSED ALL FUNCTIONAL TESTING PRIOR TO BEING RELEASED TO FINISHED GOODS. VISUAL INSPECTION OF EXTERNAL COMPONENTS FOUND NO ABNORMALITIES. FREEDOM BATTERY CHARGER AND ONBOARD BATTERIES WERE ALL TESTED FOR FUNCTIONALITY. THE BATTERY CHARGER FAILED TESTING AS BAYS 1 AND 3 ARE NOT FUNCTIONAL AND DO NOT CHARGE BATTERIES. BOTH BATTERIES ALSO FAILED FUNCTIONAL TESTING DUE TO PERMANENT FAULT AND AN OUT OF SPECIFICATION CYCLE COUNT. CUSTOMER COMPLAINT WAS REPLICATED. FAILURE INVESTIGATION FOR THIS COMPLAINT CONFIRMED THE REPORTED ISSUE. THE CUSTOMER COMPLAINT WAS REPLICATED DURING INSPECTION AND TESTING; ROOT CAUSE OF THE REPORTED MALFUNCTION OF THE BATTERY CHARGER AND BATTERIES WAS DETERMINED TO BE A FAULTY FREEDOM BATTERY CHARGER AND FAULTY FREEDOM ONBOARD BATTERIES. FAILURE INVESTIGATION IDENTIFIED NO OTHER TEST FAILURES OR DAMAGE THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. SEPARATION IN THE BATTERY HOUSING WAS COSMETIC ONLY AND DID NOT AFFECT THE FUNCTIONALITY OF THE BATTERY. COMPONENTS WERE NOT IN PATIENT USE AT TIME OF COMPLAINT. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER COMPLAINT PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. IF NEW OR ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, SYNCARDIA WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00109); (2) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00110); (3) FREEDOM BATTERY CHARGER S/N (B)(4)). THE FREEDOM ONBOARD BATTERIES AND FREEDOM BATTERY CHARGER WERE NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THE FREEDOM BATTERY CHARGER DID NOT CHARGE ANY FREEDOM ONBOARD BATTERIES. ADDITIONALLY, TWO FREEDOM ONBOARD BATTERIES WERE UNABLE TO CHARGE. THE CUSTOMER IS UNCLEAR IF THESE ISSUES ARE RELATED.

    Description of Event or Problem · 0

    THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(6) (MFR REPORT # 3003761017-2022-00109); (2) FREEDOM ONBOARD BATTERY S/N (B)(6) (MFR REPORT # 3003761017-2022-00110); (3) FREEDOM BATTERY CHARGER S/N (B)(6)). THE FREEDOM ONBOARD BATTERIES AND FREEDOM BATTERY CHARGER WERE NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THE FREEDOM BATTERY CHARGER DID NOT CHARGE ANY FREEDOM ONBOARD BATTERIES. ADDITIONALLY, TWO FREEDOM ONBOARD BATTERIES WERE UNABLE TO CHARGE. THE CUSTOMER IS UNCLEAR IF THESE ISSUES ARE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385078 SYNCARDIA FREEDOM BATTERY CHARGER BATTERY CHARGER LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown