BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINSCAN

    MDR report key: 1466610 · Received September 8, 2009

    Report

    Report Number
    8043933-2009-00006
    Event Type
    Other
    Date Received
    September 8, 2009
    Date of Event
    October 14, 2008
    Report Date
    August 12, 2009
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K994413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL THERE ARE NO NEGATIVE CLINICAL CONSEQUENCES TO BE EXPECTED FOR THE PTS. ACCORDING TO THE HOSPITAL, THE EVENTS OCCURRED ON (B)(6) 2008, (B)(6) 2009. ERRONEOUS DOSE DATA IMPLEMENTATION BY HOSPITAL RESULTING IN UNINTENDED PT TREATMENT. NO FAILURE OF THE DEVICE WAS STATED BY THE HOSPITAL. 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

    ON (B)(6), 2009, BRAINLAB AG BECAME AWARE OF A LETTER BY THE CUSTOMER STATING THAT A HIGHER THAN INTENDED RADIATION DOSE WAS DELIVERED TO 4 PTS. BRAINLAB BRAINSCAN TREATMENT PLANNING SOFTWARE VERSION 5.31 WAS INVOLVED. THE HOSPITAL STATES: AT THE TIME OF TREATMENT PLANNING COMMISSIONING BY THE HOSPITAL, THE DOSE DATA FOR SMALL CONICAL COLLIMATORS WAS OBTAINED WITH A LESS THAN OPTIMAL MEASURING DEVICE. THIS RESULTED IN ERRONEOUS DOSE DATA FOR THOSE CONICAL COLLIMATORS. THE DOSE DATA WAS ENTERED INTO THE BRAINLAB PLANNING SOFTWARE VERSION PER PROTOCOL. THE BRAINSCAN TREATMENT PLANNING SOFTWARE VERSION 5.31 WORKED AS INTENDED FOR ALL TREATMENT PLANS.

    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