BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINSCAN

    MDR report key: 1581107 · Received January 14, 2010

    Report

    Report Number
    8043933-2010-00001
    Event Type
    Other
    Date Received
    January 14, 2010
    Date of Event
    November 4, 2009
    Report Date
    December 23, 2009
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K994413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THE HOSP REPORTS NO NEGATIVE CLINICAL EFFECT TO THE PT, A RISK TO PT HEALTH COULD NOT BE EXCLUDED. THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF THE BRAINLAB EQUIPMENT. ACCORDINGLY THERE ARE NO REMEDIAL ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    FOR A STEREOTACTIC RADIOTHERAPY TREATMENT OF AN INTRACRANIAL LESION, PT POSITIONING DATA FROM ANOTHER PT HAS BEEN USED DURING ONE FRACTION OF THE PT TREATMENT. THE PT POSITIONING ERROR AT THE LINEAR ACCELERATOR WAS DETECTED BY THE HOSP DURING THE DOSE DELIVERY TO THE PT. AS A RESULT, A HEALTHY TISSUE AREA OF THE PT NOT INTENDED BY THE TREATMENT PLAN WAS IRRADIATED WITH A DOSE OF 12 GY. ACCORDING TO THE HOSP, THE PT HAS SHOWN NO SYMPTOM RELATED TO THIS ERROR SO FAR. BRAINLAB BRAINSCAN RADIOTHERAPY TREATMENT PLANNING SOFTWARE VERSION 5.32 WAS INVOLVED. THE HOSP STATES NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF THE BRAINLAB EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINSCAN RADIOTHERAPY TREATMENT PLANNING SW MUJ BRAINLAB AG BRAINSCAN V. 5.32 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other