BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERATRON

    MDR report key: 3793207 · Received January 15, 2014

    Report

    Report Number
    3006946288-2014-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 24, 2013
    Report Date
    January 10, 2014
    Manufacturer
    BEST THERATRONICS LTD
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ET
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON PAST EXPERIENCE IT IS LIKELY THAT THE CAUSE WAS FOREIGN MATERIAL INSIDE THE COLLIMATOR. THIS IS TYPICALLY RECTIFIED BY ROTATING THE GENTRY TO THE ZERO POSITION SO THAT ANY MATERIAL WILL FALL OUT. THIS IS WHAT WAS RECOMMENDED BY BTL AT THE TIME THAT THE EVENT WAS REPORTED. THE CUSTOMER SUBSEQUENTLY REPORTED THAT THE SOURCE HAD BEEN RETURNED TO THE SAFE POSITION AND THE UNIT WAS BACK IN SERVICE. THIS UNIT HAS BEEN IN USE FOR 7 YEARS WITHOUT ANY PREVENTIVE MAINTENANCE PERFORMED BY BEST THERATRONICS. THE RECOMMENDED FREQUENCY IS EVERY 5 YEARS AS PER THE OPERATOR MANUAL. THE OPERATOR NORMALLY OBSERVES BOTH THE UNIT AND THE PT AT ALL TIMES DURING THE TREATMENT. SHOULD THE SOURCE REMAIN IN THE EXPOSED OR PARTIALLY EXPOSED POSITION AT THE END OF TREATMENT, THIS WOULD BE READILY NOTICED BY THE OPERATOR AND THE PT EVACUATED FROM THE ROOM. IN THIS EVENT THE COLLIMATOR ALSO AUTOMATICALLY CLOSES TO REDUCE EXPOSURE TO PT AND/OR OPERATOR. LABELING FOR THE DEVICE INSTRUCTS THE OPERATOR ON THE STEPS TO BE FOLLOWED IN THE EVENT THAT THE SOURCE REMAINS IN THE EXPOSED POSITION AT THE END OF TREATMENT. THE SOURCE CAN THEN BE MANUALLY RETURNED TO THE FULLY SHIELDED POSITION USING THE EMERGENCY RETURN HANDLE PROVIDED WITH THE DEVICE. USE OF THE RETURN HANDLE IS FULLY DESCRIBED IN THE OPERATOR'S MANUAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE RADIOACTIVE SOURCE FAILED TO RETURN TO THE FULLY SHIELDED POSITION AT THE END OF THE PT TREATMENT. THE PT WAS REMOVED FROM THE ROOM AND THE SOURCE WAS MANUALLY RETURNED TO THE SAFE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39244 THERATRON COBALT THERAPY IWB BEST THERATRONICS LTD EQUINOX

    Patients

    Seq Age Sex Outcome Treatment
    1