BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINSCAN

    MDR report key: 1000845 · Received February 21, 2008

    Report

    Report Number
    8043933-2008-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 21, 2008
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG# 20140B. THERE HAS BEEN NO PT OR USER INJURY REPORTED; HOWEVER, A RISK TO PT HEALTH COULD NOT BE EXCLUDED AT OTHER POTENTIALLY AFFECTED HOSPITALS. SUMMARY OF EVAL: THIS POTENTIAL PROBLEM COULD BE REPRODUCED AT BRAINLAB USING THE SAME SW VERSION OF BRAINLAB AS THE INITIAL REPORTER.

    Description of Event or Problem · 1

    ON JANUARY 29, 2008, BRAINLAB RECEIVED INFO ABOUT INCORRECT ISOCENTER COORDINATE NUMBERS PRINTED ON THE TREATMENT PARAMETER SHEET GENERATED BY THE BRAINSCAN RADIOTHERAPY TREATMENT PLANNING SOFTWARE. INVESTIGATION HAS SHOWN THAT THE PROBLEM OCCURS WHEN THE FOLLOWING CONDITIONS ARE MET. CONFORMAL ARC OR DYNAMIC CONFORMAL ARC MODULE AND USING AN UN-REGISTERED IMAGE SET IN THE TREATMENT PLAN AND HAVING THAT IMAGE SET SELECTED, DURING PRINT OUT OF THE TREATMENT PARAMETERS. THE CORRESPONDING OVERLAYS FOR LASER AIDED POSITIONING ARE STILL CORRECT EVEN IF THE DESCRIBED SCENARIO OCCURS. THERE HAS BEEN NO PT OR USER INJURY AT THIS MEDICAL CENTER; HOWEVER, A POTENTIAL RISK FOR OTHER USERS COULD NOT BE EXCLUDED E.G. WHEN USING EXCLUSIVELY THE PRINTED ISOCENTER NUMBERS ON THE TREATMENT PARAMETER SHEET FOR PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINSCAN RADIOTHERAPY TREATMENT PLANNING SW MUJ BRAINLAB AG BRAINSCAN 5.2-5.31 NA

    Patients

    Seq Age Sex Outcome Treatment
    1