BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1736724 · Received June 10, 2010

    Report

    Report Number
    3004659744-2010-00006
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 10, 2010
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT COMPUTER WAS SHIPPED TO THE SITE TO RESOLVE THE REPORTED ISSUES. THE CASE WAS NOT COMPLETED WITH THE SUPERDIMENSION SYSTEM WITH THE PT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PT, BUT IN AN ABUNDANCE OF CAUTION WE ARE FILING THIS MDR BECAUSE OF THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DEVICE WAS EVALUATED ON SITE. IT WAS DISCOVERED THAT THE SITE TRIED TO REPAIR THE PC AND HAD ALTERED THE PC BY REPLACING THE VIDEO CARD INSIDE OF IT. OUR LABELING CLEARLY STATES THAT THIS IS NOT ALLOWED. AFTER REPLACING THE UNKNOWN VIDEO CARD, THE MONITOR NO LONGER FUNCTIONED. THE SITE THEN ORDERED A NEW MONITOR AND REPLACED IT. AFTER THE SITE REPLACED THE MONITOR, THE VIDEO NO LONGER WORKED CORRECTLY, AT THIS TIME SUPERDIMENSION WAS CALLED. ON (B)(4) 2011 AS SERVICE CALL WAS PERFORMED AND THE SITE RECEIVED A NEW PC. THE NEW PC WAS NOT WORKING CORRECTLY. A NEW PC AND VIDEO CONNECTOR (VIVO) WAS ORDERED AND ON (B)(4) 2010 A SERVICE CALL WAS PERFORMED TO MAKE ALL NECESSARY REPAIRS. AFTER ALL THE REPAIRS, THE SYSTEM WAS FUNCTIONING NORMALLY. AN ACCURACY TEST AND FUNCTIONAL TEST WERE BOTH PERFORMED AND BOTH PASSED. THE SITE WOULD NOT RETURN THE ORIGINAL PC AND MONITOR THAT THEY HAD CHANGED OUT ON THE SYSTEM. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT THE VIDEO CARD FAILED IN THE ORIGINAL PC, BUT WE CANNOT CONFIRM THIS. AS FOR THE SECOND PC, THIS PC VIDEO DRIVER WAS CORRUPT, HOWEVER, IT WAS NOT USED IN CASES, IT WAS FOUND DURING THIS SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR HAD GREEN LINES AND THEN FADED TO BLACK. THE SITE RESTARTED THE COMPUTER, RE-ENTERED THE PROCEDURE AND THE SAME DISPLAY ISSUE APPEARED. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1