BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERATRON

    MDR report key: 2123197 · Received November 20, 2008

    Report

    Report Number
    3006946288-2008-00001
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BEST THERATRONICS
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR NORMALLY OBSERVES BOTH THE UNIT AND PT AT ALL TIMES DURING A TREATMENT. SHOULD THE SOURCE REMAIN IN THE EXPOSED OR PARTIALLY EXPOSED POSITION AT THE END OF A TREATMENT, THE FACT WOULD BE READILY NOTICED BY THE OPERATOR AND THE PT EVACUATED FROM THE ROOM. LABELLING FOR THE DEVICE INSTRUCTS THE OPERATOR ON THE STEPS TO BE FOLLOWED IN THE EVENT THAT THE SOURCE REMAINS ON AT THE END OF A 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 SOURCE FAILED TO RETURN TO THE FULLY SHIELDED POSITION AT THE END OF A 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
    1 THERATRON COBALT TELETHERAPY IWB BEST THERATRONICS T780

    Patients

    Seq Age Sex Outcome Treatment
    1