BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAIN LAB

    MDR report key: 606282 · Received May 19, 2005

    Report

    Report Number
    606282
    Event Type
    Malfunction
    Date Received
    May 19, 2005
    Date of Event
    March 28, 2005
    Report Date
    April 26, 2005
    Manufacturer
    BRAINLAB INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BRAINLAB WOULD NOT CORRELATE LOADED IMAGES WITH THE IMAGES BEING LOADED INTRAOPERATIVELY WITH THE Z TOUCH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAIN LAB IMAGING DEVICE HAW BRAINLAB INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *