BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VTI ENTRAK

    MDR report key: 642470 · Received September 13, 2005

    Report

    Report Number
    642470
    Event Type
    Malfunction
    Date Received
    September 13, 2005
    Date of Event
    August 23, 2005
    Report Date
    September 13, 2005
    Manufacturer
    GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THIS PARTICULAR VTI SURGICAL NAVIGATION MACHINE WOULD NOT CALIBRATE DURING A PREVIOUS CASE. BECAUSE OF THIS IT WAS TESTED IN THE RECEIVING AREA PRIOR TO BEING BROUGHT INTO THE OR. THE VTI MACHINE CALIBRATED IN RECEIVING BUT IT WOULD NOT CALIBRATE IN THE OR. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE VTI MACHINE. THE PATIENT WAS BROUGHT TO PACU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VTI ENTRAK SURGICAL NAVIGATION SYSTEM IZL GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION, INC. 1005705-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR