BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM ONBOARD BATTERY

    MDR report key: 4953239 · Received July 24, 2015

    Report

    Report Number
    3003761017-2015-00241
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE, ALTHOUGH THE FREEDOM ONBOARD BATTERIES WERE LOW CAPACITY, THEY DID NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. IN ADDITION, THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF EXTERNAL WALL POWER. THE FREEDOM ONBOARD BATTERIES WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    (B)(4) FOLLOW-UP REPORT 1 (2 OF 2).

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES TWO FREEDOM ONBOARD BATTERIES THAT ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: FREEDOM ONBOARD BATTERY S/N (B)(4); MFR RPT. #3003761017-2015-00238 & FREEDOM ONBOARD BATTERY S/N (B)(4). THE CUSTOMER REPORTED THAT THE PATIENT REPORTED THAT THE FREEDOM ONBOARD BATTERIES HAVE A LOWER CAPACITY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S ONBOARD BATTERIES WERE EXCHANGED. THERE WAS NO REPORTED PATIENT IMPACT.

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES TWO FREEDOM ONBOARD BATTERIES THAT ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2015-00238) AND FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2015-00241). THE CUSTOMER REPORTED THAT THE PATIENT REPORTED THAT THE FREEDOM ONBOARD BATTERIES HAVE A LOWER CAPACITY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S ONBOARD BATTERIES WERE EXCHANGED. THERE WAS NO REPORTED PATIENT IMPACT. THE FREEDOM ONBOARD BATTERY WAS RETURNED TO SYNCARDIA FOR EVALUATION. ONBOARD BATTERY S/N (B)(4) EXHIBITED A HOUSING WELD SEPARATION AT THE GAS GAUGE DISPLAY; ITS EXPIRATION DATE WAS AUGUST 2015. THE BATTERIES' SMBUS (SYSTEM MANAGEMENT BUS) DATA DID NOT REVEAL ANY PERMANENT FAULTS OR ABNORMALITIES. WITH THE EXCEPTION OF THE SEPARATED HOUSING ON ONBOARD BATTERY S/N (B)(4), THE BATTERY SUCCESSFULLY PASSED FUNCTIONAL TESTING, WHICH INCLUDED CHARGING AND DISCHARGING THE BATTERIES. THE CUSTOMER-REPORTED ISSUE COULD NOT BE CONFIRMED. RISK TO THE PATIENT WAS LOW 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. BECAUSE ONBOARD BATTERY S/N (B)(4) HAD A HOUSING SEPARATION AND WAS BEYOND ITS EXPIRATION DATE (AUGUST 2015), IT WAS TAKEN OUT OF SERVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483865 SYNCARDIA FREEDOM ONBOARD BATTERY BATTERY LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR