BEUDAMED
    FDA Adverse Event Other Summary report: N

    SL15 LINEAR ACCELERATOR

    MDR report key: 564011 · Received January 7, 2005

    Report

    Report Number
    9617016-2005-00004
    Event Type
    Other
    Date Received
    January 7, 2005
    Date of Event
    December 3, 2004
    Report Date
    January 7, 2005
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FAULTY SHORT SHADOW TRAY WAS INCORRECTLY REPLACED WITH A STANDARD SHADOW TRAY, LEADING TO A CLEARANCE DIFFERENCE BETWEEN SHADOW TRAY BASE AND ISOCENTRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL15 LINEAR ACCELERATOR MEDIAL LINEAR ACCELERATOR IYE ELEKTA LIMITED * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other