BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMABEAM 100

    MDR report key: 4950227 · Received July 21, 2015

    Report

    Report Number
    3006946288-2015-00001
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Manufacturer
    BEST THERATRONICS LTD.
    Product Code
    IWB
    PMA / PMN Number
    K142219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOURCE COULD NOT BE RETURNED TO THE SHIELDED POSITION BECAUSE A SCREW HAD FALLEN INTO THE SOURCE DRAWER, CAUSING IT TO BECOME JAMMED. THE SCREW HAD FALLEN OUT OF THE JAW ADJUSTER ROD COUPLING AND INTO THE SOURCE CHAMBER WHEN THE GANTRY WAS AT 180 DEGREES. THE JAW ADJUSTER KNOB CAN ONLY BE INSTALLED AFTER THE COVERS ARE INSTALLED. THE SETSCREW MAY NOT HAVE BEEN SECURELY FASTENED ON A SUBSEQUENT SERVICE VISIT THAT REQUIRED THE COVERS TO BE REMOVED. THE OPERATOR NORMALLY OBSERVES BOTH THE UNIT AND THE PATIENT AT ALL TIMES DURING TREATMENT. SHOULD THE SOURCE REMAIN IN THE EXPOSED POSITION AT THE END OF TREATMENT, THE FACT WOULD BE READILY NOTICED BY THE OPERATOR AND THE PATIENT EVACUATED FROM THE ROOM. LABELING FOR THE DEVICE INSTRUCTS THE OPERATOR ON THE STEPS TO BE FOLLOWED IN THE EVENT THAT A SOURCE REMAINS IN THE EXPOSED POSITION AT THE END OF TREATMENT.

    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 SAFELY REMOVED FROM THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473653 GAMMABEAM 100 COBALT THERAPY IWB BEST THERATRONICS LTD. 80

    Patients

    Seq Age Sex Outcome Treatment
    1