BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINSCAN

    MDR report key: 1562527 · Received December 17, 2009

    Report

    Report Number
    8043933-2009-00012
    Event Type
    Other
    Date Received
    December 17, 2009
    Report Date
    December 4, 2009
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K994413
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NUMBER OF PTS THAT MIGHT HAVE BEEN TREATED WITH A LOWER THAN INTENDED RADIATION DOSE AT THIS HOSPITAL, AND THE POTENTIAL CLINICAL EFFECTS HAVE NOT BEEN REVEALED BY THE HOSPITAL TO BRAINLAB, THUS IS UNK TO BRAINLAB AT THIS POINT OF TIME. ACCORDING TO THE HOSPITAL, THE BRAINSCAN TREATMENT PLANNING SOFTWARE HAS BEEN USED WITH THE ERRONEOUS DOSE DATA SINCE 2005. ERRONEOUS DOSE DATA IMPLEMENTATION BY HOSPITAL POTENTIALLY RESULTING IN UNINTENDED PT TREATMENT. THE BRAINLAB INSTRUCTIONS FOR THE ACCORDING DOSE DATA ACQUISITION BY THE HOSPITAL WERE CORRECT AND COMPLETE. THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. CORRECTIVE AND PREVENTIVE ACTIONS: SINCE THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT, THERE ARE NO REMEDIAL ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    THE HOSPITAL STATES, THAT INCORRECT DOSE DATA REGARDING THE LINEAR ACCELERATOR CALIBRATION WAS ENTERED INTO THE BRAINLAB TREATMENT PLANNING SOFTWARE AT THE TIME OF THE TREATMENT PLANNING COMMISSIONING. AS A RESULT, AN APPROXIMATELY 15% LOWER THAN INTENDED RADIATION DOSE MIGHT HAVE BEEN DELIVERED TO PTS SINCE (B)(6) 2005 AT THIS HOSPITAL. BRAINLAB BRAINSCAN TREATMENT PLANNING SOFTWARE VERSION 5.31 WAS INVOLVED. THE INITIAL DOSE DATA ACQUISITION, ALL SUBSEQUENT MAINTENANCE AND QUALITY ASSURANCE OF THE DOSE DATA IMPLEMENTED INTO THE BRAINLAB TREATMENT PLANNING SOFTWARE IS IN THE RESPONSIBILITY OF THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1