BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON SYSTEM

    MDR report key: 649116 · Received November 21, 2005

    Report

    Report Number
    649116
    Event Type
    Malfunction
    Date Received
    November 21, 2005
    Date of Event
    November 21, 2005
    Report Date
    November 21, 2005
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHEN PLUGGING IN THE STEALTHSTATION TREON, THE ELECTRICAL CIRCUIT BREAKER IN THE BUILDING TRIPPED, CAUSING LOSS OF POWER TO THE ANESTHESIA MACHINE AND THE SURGICAL LIGHTS. POWER FOR THE ANESTHESIA MACHINE WAS RESTORED BY PLUGGING INTO A DIFFERENT OUTLET. ANESTHETIC GAS MONITORING IS NOT AVAILABLE FOR THE FIRST 5 MINUTES AFTER A POWER LOSS, WHILE THE MONITOR RE-CALIBRATES.THIS PROBLEM IS RELATED TO AN EARLIER MEDSUN REPORT FROM THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON SYSTEM SURGICAL NAVIGATION SYSTEM HAW MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES TREON *

    Patients

    Seq Age Sex Outcome Treatment
    1 *