BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINLAB

    MDR report key: 284665 · Received July 3, 2000

    Report

    Report Number
    MW1019227
    Event Type
    Malfunction
    Date Received
    July 3, 2000
    Date of Event
    April 26, 2000
    Report Date
    June 26, 2000
    Manufacturer
    BRAINLAB USA, INC.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE IS MANUFACTURED IN EUROPE AND UTILIZES EUROPEAN CONVENTION OF VIEWING CT SCANS OF THE HEAD WITH THE PT'S RIGHT ON THE VIEWER'S RIGHT AS OPPOSED TO THE AMERICAN CONVENTION WHICH IS THE OPPOSITE. INFO GAINED AT SURGERY TRANSFERRED TO MONITOR FROM DESCRIPTION OF SURGEON TRACED ON CT SCAN LED TO PLANNING OF TREATMENT ON THE OPPOSITE SIDE FROM THAT PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINLAB STEREOTACTIC RADIOTHERAPY TREATMENT PLANNING MUJ BRAINLAB USA, INC. BRAIN SCAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other