BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMAPLAN

    MDR report key: 207034 · Received January 20, 1999

    Report

    Report Number
    9612186-1999-00001
    Event Type
    Malfunction
    Date Received
    January 20, 1999
    Date of Event
    December 22, 1998
    Report Date
    December 22, 1998
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    LMX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE TREATMENT PLANNING SOFTWARE, THE PHYSICIAN USED THE PLUG SHIELDS FEATURE, AND THEN MERGED THE PLUG PATTERNS. HE THEN CREATED A NEW PLAN AND CHOSE THE "COPY EXISTING PLAN" FEATURE. UPON COPYING, THE LEKSELL GAMMAPLAN SOFTWARE GAVE AN ERROR STATING THAT PLUG PATTERN "HELMET 18A NOT FOUND." THE SHOT MENU SHOWED ONLY THE PATTERN "NONE" FOR EACH OF THE SHOTS. THE PLUG MENU SHOWED NO PLUGS. HOWEVER, THE PROTOCOL PRINTOUT GAVE TIMES AS IF THE PLUGS STILL EXISTED WITHOUT PRINTING ANY PLUGS AND THE ISODOSE CURVES BEHAVED AS IF THE PLUGS WERE STILL THERE. THIS WAS TRUE FOR BOTH THE ORIGINAL PLAN AND FOR THE COPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMAPLAN TREATMENT PLANNING SOFTWARE LMX ELEKTA INSTRUMENT AB VERSION 5.12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other