BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL SERIES

    MDR report key: 2440575 · Received January 20, 2012

    Report

    Report Number
    9617016-2012-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 18, 2012
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K963624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS SITUATION IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETED, MORE DETAILS AND A CONCLUSION WILL BE PROVIDED.

    Description of Event or Problem · 1

    WHILE INSPECTING THE GANTRY, 2 SHEARED OFF BOLTS WERE FOUND, AND A 3RD BOLT SHEARED WHEN THE ENGINEERS TRIED TO UNDO IT. THE 4TH BOLT WAS INTACT, SO IT WAS REMOVED COMPLETELY. THERE WAS INSPECTION OF OTHER MACHINERS WHICH ARE USED FOR VMAT TREATMENTS, AND SO FAR NO PROBLEM. THIS HAS HAPPENED ON JUNIPER MACHINE (B)(4), AND MOST OF OUR VMAT TREATMENTS ARE DONE ON THIS MACHINE. DURING VMAT'S THE GANTRY CAN SPEED UP AND SLOW DOWN AT AN ALARMING RATE, AND IT IS THIS THAT HAS CAUSED THESE BOLTS TO SHEER OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL SERIES LINEAR ACCELERATOR IYE ELEKTA LIMITED 151556 -HW

    Patients

    Seq Age Sex Outcome Treatment
    1