BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINSCAN

    MDR report key: 1654424 · Received April 6, 2010

    Report

    Report Number
    8043933-2010-00006
    Event Type
    Other
    Date Received
    April 6, 2010
    Date of Event
    September 12, 2003
    Report Date
    March 18, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K994413
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NUMBER OF POTENTIALLY CONCERNED PTS AT THIS HOSP AND POTENTIAL CLINICAL CONSEQUENCES - IF ANY- ARE UNK TO BRAINLAB. THE ERRONEOUS DOSE DATA HAD BEEN IMPLEMENTED BY THE HOSP INTO THE BRAINSCAN TREATMENT PLANNING SOFTWARE IN (B)(6) 2003. ERRONEOUS DOSE DATA IMPLEMENTATION BY HOSP POTENTIALLY RESULTING IN UNINTENDED PT TREATMENT. THE BRAINLAB INSTRUCTIONS FOR THE ACCORDING DOSE DATA ACQUISITION BY THE HOSP WERE CORRECT AND COMPLETED. THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. CORRECTIVE AND PREVENTIVE ACTIONS: THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. NEVERTHELESS, BRAINLAB INTENDS TO PROVIDE A SAFE USE REMINDER TO EXISTING BRAINLAB RADIOTHERAPY TREATMENT PLANNING SOFTWARE USERS.

    Description of Event or Problem · 1

    THE HOSPITAL INFORMED THAT THE DOSE DATA, WHICH WAS ACQUIRED AND IMPLEMENTED BY THE HOSPITAL INTO THE BRAINLAB TREATMENT PLANNING SOFTWARE IN (B)(6) 2003, WAS FOUND TO BE INCORRECT FOR SMALL TREATMENT FIELDS SHAPED BY THE BRAINLAB CONICAL COLLIMATORS. AS A RESULT, UNINTENDED RADIATION DOSE MIGHT HAVE BEEN DELIVERED TO PTS WHEN USING THOSE SMALL TREATMENT FIELDS. BRAINLAB BRAINSCAN TREATMENT PLANNING SOFTWARE VERSION 5.31 IS INVOLVED. NO FAILURE OF THE BRAINLAB DEVICE WAS STATED BY THE HOSP.

    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