BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERATRON

    MDR report key: 2916127 · Received December 24, 2012

    Report

    Report Number
    3006946288-2012-00001
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Manufacturer
    BEST THERATRONICS LTD
    Product Code
    IWB
    PMA / PMN Number
    K850543
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOURCE COULD NOT RETURN TO THE SHIELDED POSITION BECAUSE A COUPLING IN THE SOURCE DRAWER FAILED AND BECAME DETACHED. THE SOURCE DRAWER WAS NOT MANUFACTURED BY BEST THERATRONICS AND HAD BEEN REPLACED BY THE USER FROM A LOCAL MFR IN INDIA. THE OPERATOR NORMALLY OBSERVES BOTH THE UNIT AND THE PT AT ALL TIMES DURING TREATMENT. SHOULD THE SOURCE REMAIN IN THE EXPOSED OR PARTIALLY EXPOSED POSITION AT THE END OF TREATMENT, THE FACT WOULD BE READILY NOTICED BY THE OPERATOR AND THE PT EVACUATED FROM THE ROOM. 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 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 THERAPY IWB BEST THERATRONICS LTD 780C

    Patients

    Seq Age Sex Outcome Treatment
    1