BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMS

    MDR report key: 285736 · Received July 10, 2000

    Report

    Report Number
    8022247-2000-00005
    Event Type
    Malfunction
    Date Received
    July 10, 2000
    Date of Event
    June 8, 2000
    Report Date
    June 27, 2000
    Manufacturer
    HELAX AB
    Product Code
    MVJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCORRECT DOSE IS CALCULATED WHEN USING COLLAPSED CONE FOR CERTAIN BEAM ANGLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMS RADIATION TREATMENT PLANNING SYSTEM MVJ HELAX AB TMS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other