BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 3831973 · Received March 7, 2014

    Report

    Report Number
    3005594788-2014-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 7, 2014
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K122951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION COULD NOT BE REPLICATED UPON TROUBLESHOOTING THE CONTROLLER UNIT AT THE CUSTOMER SITE. IT IS BELIEVED THAT THE UNEXPECTED SHUTDOWN OF THE UNIT WAS ATTRIBUTABLE TO THE OLD DESIGN OF THE HIGH VOLTAGE CABLE. THIS COMPONENT WAS REPLACED WITH THE UPGRADED DESIGN. UNIT WAS RETESTED WITH NO REPEAT OCCURRENCE OF THE INITIAL MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A BILATERAL IORT BRACHYTHERAPY PROCEDURE FOR BREAST CANCER. DURING THE RADIATION TREATMENT OF HER BREAST, THE MAIN CONTROLLER UNIT STOPPED DELIVERING THE RADIATION TREATMENT. THE PATIENT RECEIVED LESS THAN 95% OF THE PRESCRIPTIVE DOSE REQUIRED. NO SERIOUS INJURY WAS SUSTAINED BY THE PATIENT. THE TREATING PHYSICIAN INDICATED THAT THE PATIENT WAS SCHEDULED FOR EXTERNAL BEAM RADIATION THERAPY TO COMPLETE THE PROCEDURE. XOFT INTERNAL TRACKING NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138872 XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM CONTROLLER JAD XOFT, A SUBSIDIARY OF ICAD, INC. 110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention