BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISEPLAN 2.0

    MDR report key: 484110 · Received September 15, 2003

    Report

    Report Number
    1225524-2003-00016
    Event Type
    Other
    Date Received
    September 15, 2003
    Date of Event
    August 20, 2003
    Report Date
    September 15, 2003
    Manufacturer
    ELEKTA LTD
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED ELEKTA ON AUGUST 28, 2003 TO ADVISE THAT A MIS-ADMINISTRATION HAD OCCURRED AT THEIR FACILITY. A LUNG PT WAS PLANNED WITH AN OBLIQUE PAIR OF 50 DEGREE WEDGES. THE PLAN THAT WAS TRANSFERRED DID NOT HAVE WEDGES. TREATMENT COMMENCED AND THE DOSE ERROR WAS NOTED 7 DAYS LATER DURING DIODE CHECKS DURING THE 5TH TREATMENT FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISEPLAN 2.0 TREATMENT PLANNING SYSTEM MUJ ELEKTA LTD PRECISEPLAN 2.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other PRECISE DIGITAL ACCELERATOR (PRECISE DESKTOP).