BEUDAMED
    FDA Adverse Event Other Summary report: N

    SL75-5 SERIES

    MDR report key: 492845 · Received October 29, 2003

    Report

    Report Number
    1225524-2003-00018
    Event Type
    Other
    Date Received
    October 29, 2003
    Date of Event
    September 23, 2003
    Report Date
    October 28, 2003
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE TIME OF THE INCIDENT ONE RADIOGRAPHER WAS ROTATING THE GANTRY AT THE SAME TIME A SECOND RADIOGRAPHER WAS ATTEMPTING TO CHANGE AN ACCESSORY ON THE SHADOW TRAY WHICH IS ATTACHED TO THE RADIATION HEAD OF THE SL75-5. BOTH ITEMS FELL ONTO THE PT'S MASK, BEFORE HITTING THEIR SHOULDER AND FALLING TO THE FLOOR. THE PT WAS REPORTED TO HAVE BEEN "LIGHTLY INJURED" ON THE FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL75-5 SERIES LINEAR ACCELERATOR IYE ELEKTA LIMITED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other