BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINSCAN

    MDR report key: 1546731 · Received November 24, 2009

    Report

    Report Number
    8043933-2009-00009
    Event Type
    Other
    Date Received
    November 24, 2009
    Report Date
    October 30, 2009
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K994413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL THERE ARE NO NEGATIVE CLINICAL CONSEQUENCE TO BE EXPECTED FOR THE PATIENTS. 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 PATIENT TREATMENT. THE BRAINLAB INSTRUCTIONS FOR THE ACCORDING DOSE DATA ACQUISITION BY THE HOSPITAL WAS 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

    BRAINLAB HAS BEEN INFORMED BY THE HOSPITAL THAT UNINTENDED RADIATION DOSE MIGHT HAVE BEEN DELIVERED TO PATIENTS SINCE 2005 WHEN USING SMALL TREATMENT FIELDS. BRAINLAB BRAINSCAN TREATMENT PLANNING SOFTWARE VERSION 5.31 WAS INVOLVED. THE HOSPITAL STATES, THAT AT THE TIME OF TREATMENT PLANNING COMMISSIONING, THE HOSPITAL OBTAINED THE DOSE DATA FOR SMALL TREATMENT FIELDS SHAPED BY THE BRAINLAB M3 MICRO-MULTILEAF-COLLIMATOR WITH A LESS THAN OPTIMAL MEASURING DEVICE. THIS RESULTED IN ERRONEOUS DOSE DATA ACQUISITION BY THE HOSPITAL FOR THOSE SMALL TREATMENT FIELDS. THE DOSE DATA WAS ENTERED INTO THE BRAINLAB PLANNING SOFTWARE. NO FAILURE OF THE BRAINLAB DEVICE WAS STATED BY 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