BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VTI ENTRAK

    MDR report key: 642468 · Received September 13, 2005

    Report

    Report Number
    642468
    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

    VTI SURGICAL NAVIGATION MACHINE WOULD NOT CALIBRATE. A DIFFERENT VTI MACHINE, CORD, TRANSMITTER, AND RECEIVER WERE BROUGHT IN. THE HELMET WAS REMOVED AND RE-APPLIED PER THE SURGEON'S INSTRUCTIONS. THE SECOND MACHINE ALSO WOULD NOT CALIBRATE. THE PROCEDURE WAS COMPLETED WITHOUT A VTI MACHINE. PATIENT WAS SENT 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 52 YR