BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAIN-LAB

    MDR report key: 1274169 · Received December 12, 2008

    Report

    Report Number
    MW5009344
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    December 4, 2008
    Report Date
    December 12, 2008
    Manufacturer
    BRAIN-LAB, INC.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OR FOR IMAGE-GUIDED F.E.E.S. FUNCTIONAL ENDOSCOPIC SINUS SURGERY-FOR NASAL MASS; PROCEDURE COULD NOT BE COMPLETED AS BOOKED DUE TO MALFUNCTION WITH THE BRAIN-LAB SYSTEM. THERE WAS NO HARM TO THE PATIENT WHO WAS DISCHARGED LATER THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAIN-LAB BRAIN-LAB MUJ BRAIN-LAB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR