BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM A/C POWER SUPPLY

    MDR report key: 4703968 · Received April 15, 2015

    Report

    Report Number
    3003761017-2015-00129
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 7, 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

    THE PATIENT SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER AND FREEDOM A/C POWER SUPPLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE FREEDOM AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE FREEDOM AC POWER SUPPLY PASSED ALL REQUIRED FUNCTIONAL TESTING. DURING TESTING, THE AC POWER SUPPLY WAS SUCCESSFULLY MATED TO BOTH A FREEDOM BATTERY CHARGER AND A FREEDOM POWER ADAPTOR WITH NO ANOMALIES NOTED. THE CUSTOMER-REPORTED "DISCHARGE OF ONBOARD BATTERIES WHILE CONNECTED TO AC POWER" COULD NOT BE DUPLICATED AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED ISSUE POSES A LOW RISK TO A PATIENT BECAUSE THOUGH THE CUSTOMER REPORTED THAT THE FREEDOM ONBOARD BATTERIES WERE DISCHARGING, THE FREEDOM DRIVER WOULD CONTINUE TO PROVIDE ITS LIFE-SUSTAINING FUNCTIONS.

    Additional Manufacturer Narrative · 1

    THE PATIENT SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER AND FREEDOM A/C POWER SUPPLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM ONBOARD BATTERIES WERE DISCHARGED WHILE THE PATIENT'S FREEDOM DRIVER WAS CONNECTED TO EXTERNAL WALL POWER BY THE A/C POWER SUPPLY, THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. IN ADDITION, PATIENTS ARE PROVIDED WITH SEVERAL ONBOARD BATTERIES. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND IS REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: PRIMARY FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00128) AND FREEDOM A/C POWER SUPPLY S/N (B)(4) (MFR REPORT # 3003761017-2015-00129). THE CUSTOMER REPORTED THAT THE PATIENT'S FREEDOM ONBOARD BATTERIES DISCHARGED WHILE HIS FREEDOM DRIVER WAS 1 BRAND NAME SYNCARDIA FREEDOM A/C POWER SUPPLY CONNECTED TO EXTERNAL WALL POWER BY THE A/C POWER SUPPLY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT ATTEMPTED TO RESOLVE THE ISSUE BY SWITCHING TO A DIFFERENT POWER ADAPTOR, WHICH CONNECTS THE A/C POWER SUPPLY TO THE DRIVER. HOWEVER, THE ISSUE DID NOT RESOLVE.

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: (1) PRIMARY FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00128) AND (2) FREEDOM A/C POWER SUPPLY S/N (B)(4) (MFR REPORT # 3003761017-2015-00129). THE CUSTOMER REPORTED THAT THE PATIENT'S FREEDOM ONBOARD BATTERIES DISCHARGED WHILE HIS FREEDOM DRIVER WAS CONNECTED TO EXTERNAL WALL POWER BY THE A/C POWER SUPPLY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT ATTEMPTED TO RESOLVE THE ISSUE BY SWITCHING TO A DIFFERENT POWER ADAPTOR, WHICH CONNECTS THE A/C POWER SUPPLY TO THE DRIVER. HOWEVER, THE ISSUE DID NOT RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252586 SYNCARDIA FREEDOM A/C POWER SUPPLY POWER SUPPLY LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR