BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1583572 · Received January 6, 2010

    Report

    Report Number
    3004962788-2010-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    December 8, 2009
    Report Date
    January 6, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS PERFORMED AT THIS SITE ON 12/11/09. A COMPONENT OF THE SYSTEM, THE COMPUTER PC, WAS REPLACED. THE PC WAS RETURNED FOR ANALYSIS, AND THE REPORT SHOWED THAT THE FUNCTIONALITY OF THE PC WAS COMPROMISED BY THE INSTALLATION OF ADDITIONAL SOFTWARE ON THE PC BY THE SITE. IN ADDITION, THE GRAPHICS SETTINGS HAD BEEN CHANGED. THE USER MANUAL STATES: "YOUR SUPERDIMENSION / BRONCHUS SYSTEM COMES WITH ALL THE NECESSARY APPLICATION SOFTWARE PREINSTALLED. NO FURTHER SOFTWARE INSTALLATION IS REQUIRED. CAUTION INSTALLING ANY OTHER SOFTWARE ON THE SUPERDIMENSION/BRONCHUS SYSTEM WILL DAMAGE THE SYSTEM. NO OTHER SOFTWARE SHOULD BE INSTALLED ON THE SUPERDIMENSION/BRONCHUS 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

    IT WAS REPORTED THAT THE COMPUTER, A COMPONENT OF THE SUPERDIMENSION SYSTEM, WOULD NOT BOOT UP. THE SITE REPORTED GETTING A MESSAGE ON THE SCREEN STATING THE VIDEO SIGNAL WAS NOT DETECTED EVEN AFTER MULTIPLE POWER CYCLES. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION INC. I4902004

    Patients

    Seq Age Sex Outcome Treatment
    1