BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN RT DOSE 3.0.2 PLATFORM

    MDR report key: 2195065 · Received July 13, 2011

    Report

    Report Number
    8043933-2011-00014
    Event Type
    Other
    Date Received
    July 13, 2011
    Date of Event
    September 1, 2008
    Report Date
    June 17, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K053584
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL, THERE ARE NO NEGATIVE CLINICAL CONSEQUENCES TO BE EXPECTED REGARDING THE PATIENT TREATMENTS IN QUESTION. THE DOSE DATA IN QUESTION HAD BEEN IMPLEMENTED BY THE HOSPITAL INTO THE INPLANT RT DOSE RADIOTHERAPY TREATMENT PLANNING SOFTWARE IN (B)(6) 2008. WHEN USING THESE SMALL TREATMENT FIELDS, A RADIATION DOSE NOT AS ACCURATE TO THE PLANNED RADIATION DOSE AS WOULD BE DESIRABLE, MIGHT HAVE BEEN DELIVERED TO PATIENTS. 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: BRAINLAB INTENDS TO REMIND THIS HOSPITAL OF THE ACCORDING RELEVANT INFORMATION DETAILS AVAILABLE IN THE BRAINLAB USER GUIDES. SINCE THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. THE BRAINLAB INSTRUCTIONS FOR THE ACCORDING DOSE DATA ACQUISITION BY THE HOSPITAL WERE CORRECT AND COMPLETE. BRAINLAB MEASURES FOR THE RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. THERE ARE NO FURTHER CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    THE DOSE DATA, WHICH WAS ACQUIRED AND IMPLEMENTED BY THE HOSPITAL INTO THE BRAINLAB IPLAN RT DOSE RADIOTHERAPY TREATMENT PLANNING SOFTWARE VERSION 3.0.2 IN (B)(6) 2008, APPEARED TO BE NOT AS ACCURATE FOR SMALL TREATMENT FIELDS SHAPED BY A MULTILEAF-COLLIMATOR AS WOULD BE DESIRABLE. AS A RESULT, WHEN USING THESE SMALL TREATMENT FIELDS, A RADIATION DOSE NOT AS ACCURATE TO THE PLANNED RADIATION DOSE AS WOULD BE DESIRABLE, MIGHT HAVE BEEN DELIVERED TO PATIENTS. NO FAILURE OF THE BRAINLAB DEVICE WAS STATED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPLAN RT DOSE 3.0.2 PLATFORM RADIOTHERAPY TREATMENT PLANNING SW MUJ BRAINLAB AG 21213B NA

    Patients

    Seq Age Sex Outcome Treatment
    1