BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 5670202 · Received May 20, 2016

    Report

    Report Number
    3005594788-2016-00001
    Event Type
    Malfunction
    Date Received
    May 20, 2016
    Date of Event
    April 29, 2016
    Report Date
    April 29, 2016
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K072683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER FAILURE ANALYSIS: THE E102 ERROR CODE AS REPORTED BY THE FACILITY IS ATTRIBUTED TO A POWER INTERRUPT DURING BOOT-UP OR A SIGNAL LOSS OCCURRING BETWEEN THE CONTROLLER AND ITS ELECTROMETER. THE ERROR STATE IS CLEARED BY THE APPLICATION OF THE USB SERVICE KEY, WHICH THE OPERATOR DID NOT HAVE IN THE VICINITY OF THE CONTROLLER, THUS DELAYING THE PROCEDURE. ADDITIONAL DELAY IN THE PROCEDURE OCCURRED BY THE OPERATOR NOT FOLLOWING THE RECOVERY INSTRUCTIONS AS PROVIDED IN THE CONTROLLER TROUBLESHOOTING GUIDE UNTIL INSTRUCTED BY XOFT FIELD SERVICE. THE E221 ERROR CODE IS A FAULT CONDITION ATTRIBUTED TO A BAD X-RAY SOURCE. UNDER SUCH CONDITION, THE TROUBLESHOOTING GUIDE INSTRUCTS THE OPERATOR TO REPLACE THE DEVICE, WHICH WAS THE ACTION TAKEN BY THE FACILITY. THE INDICATED FAILURE POSES NO RISK TO THE SAFETY OF THE PATIENT, AS THE CONDITION IS DETECTED DURING THE DEVICE CALIBRATION BEFORE ACTIVE THERAPY IS DELIVERED TO THE PATIENT.

    Description of Event or Problem · 1

    A PATIENT UNDERGOING BRACHYTHERAPY TREATMENT FOR BREAST CANCER EXPERIENCED A DELAY IN THE PROCEDURE DUE TO THE BRACHYTHERAPY CONTROLLER SYSTEM REGISTERING AN E102 ERROR CODE DURING THE SYSTEM BOOT-UP AND THE OPERATOR (OR TREATING FACILITY) NOT FOLLOWING THE RECOVERY INSTRUCTIONS AS ADVISED FOR RESTORING THE SYSTEM. THE FACILITY CONTACTED XOFT FIELD SERVICE TO INTERVENE IN THE TROUBLESHOOTING. FIELD SERVICE ADVISED THE OPERATOR TO USE THE USB SERVICE KEY PROVIDED WITH THE CONTROLLER TO RESTORE THE SYSTEM. UPON RECEIVING INSTRUCTION, THE OPERATOR COULD NOT LOCATE THE KEY AND WAS REQUIRED TO RETRIEVE THE DEVICE FROM ANOTHER LOCATION IN THE FACILITY WHILE THE PATIENT REMAINED UNDER ANESTHESIA. ONCE RETRIEVED, THE DEVICE WAS USED AS INSTRUCTED BY FIELD SERVICE AND THE CONTROLLER WAS RESTORED. DURING THE NEXT STEP OF THE PROCESS, THE OPERATOR ENCOUNTERED AN E221 ERROR CODE DURING THE CALIBRATION OF THE X-RAY SOURCE, AT WHICH POINT, WAS ADVISED BY XOFT FIELD SERVICE TO REPLACE THE DEVICE WITH A SECOND SOURCE. THE SECOND DEVICE CALIBRATED WITH NO FURTHER INCIDENT, AND THE PATIENT'S PROCEDURE WAS COMPLETED. NO SERIOUS INJURY TO THE PATIENT WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS A FOLLOW-UP TO MDR # 3005594788-2016-00001. THE DATE OF EVENT PREVIOUSLY REPORTED IS INCORRECT. THE CORRECT DATE OF EVENT IS (B)(6) 2016. ALL OTHER INFORMATION AS PREVIOUSLY REPORTED IS UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323962 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM CONTROLLER JAD XOFT, A SUBSIDIARY OF ICAD, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other