BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERATRON

    MDR report key: 1381426 · Received March 9, 2009

    Report

    Report Number
    3006946288-2009-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    February 3, 2009
    Report Date
    March 3, 2009
    Manufacturer
    BEST THERATRONICS LTD.
    Product Code
    IWD
    PMA / PMN Number
    K983917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR NORMALLY OBSERVES BOTH THE UNIT AND PATIENT 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 PATIENT 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 PATIENT TREATMENT. THE PATIENT 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 THERAPY IWD BEST THERATRONICS LTD. ELITE 100

    Patients

    Seq Age Sex Outcome Treatment
    1