BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2224751 · Received August 26, 2011

    Report

    Report Number
    3004962788-2011-00043
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 26, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN WORKING WITH THE DISTRIBUTOR AND THE SITE, IT WAS DISCOVERED THAT AT SOME POINT IN THE INSTALLATION OF THE ANTI-VIRUS SOFTWARE THE HOSPITAL INSTALLED, THE IT STAFF TURNED ON THE WINDOWS FIREWALL. THE FIREWALL BEING TURNED ON DISRUPTED COMMUNICATION WITH THE LSS AND THE IPC. THIS EXPLAINS THE ISSUES AND ERROR MESSAGES THE SITE WAS SEEING. ONCE THE FIREWALL WAS TURNED OFF, THE SYSTEM ONCE AGAIN OPERATED NORMALLY. THE SYSTEM FUNCTIONED AS DESIGNED. CAUTION FROM THE USER MANUAL STATES: ONLY THIRD-PARTY SOFTWARE, SUCH AS ANTIVIRUS AND ENCRYPTION SOFTWARE, AUTHORIZED BY SUPERDIMENSION, INC. MAY BE INSTALLED ON THE SUPERDIMENSION I·LOGIC SYSTEM. SUCH SOFTWARE MUST BE INSTALLED AND CONFIGURED ACCORDING TO SUPERDIMENSION SPECIFICATIONS AND BY QUALIFIED INFORMATION TECHNOLOGY PROFESSIONALS. INSTALLATION OF NON-AUTHORIZED SOFTWARE MAY RESULT IN DAMAGE TO THE SYSTEM. THERE WAS NO INJURY TO THE PATIENT REPORTED. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED DUE TO THE ADDITIONAL POTENTIAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEY WERE SETTING UP FOR A PROCEDURE AND RECEIVED AN ERROR MESSAGE #200 STATING "THE LOCALIZATION SUBSYSTEM (LSS) PROCESSOR WAS NOT DETECTED. PLEASE WAIT A FEW SECONDS AND PRESS RETRY. IF THE PROBLEM PERSISTS, PRESS THE LSS RESET BUTTON ON THE FRONT PANEL, WAIT 10 SECONDS AND PRESS RETRY". THE PROCESS WAS FOLLOWED, HOWEVER, THE SYSTEM FAILED TO RESPOND. THEREFORE, THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE CASE WAS COMPLETED FOR THE PATIENT USING OTHER METHODS. IN ADDITION, IT WAS REPORTED THAT THEY HAD RECENTLY INSTALLED ANTI-VIRUS SOFTWARE ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1