BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1675260 · Received April 21, 2010

    Report

    Report Number
    3004962788-2010-00012
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 21, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS PERFORMED AT THIS SITE ON (B)(6) 2010. DURING THE SERVICE CALL VISIT, IT WAS NOTICED THAT THE USB DRIVE THAT WAS USED WAS NOT THE ONE SUPPLIED WITH THE SYSTEM. THE APPROPRIATE USB WAS TESTED WITH THE SYSTEM AND THE SYSTEM FUNCTIONED NORMALLY. AT THIS TIME, THERE HAVE BEEN NO FURTHER REPORTS OF THIS ISSUE REPORTED FROM THE SITE. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME. THE USER MANUAL STATES: "CAUTION: TO SAFELY EXTRACT THE REMOVABLE DISK (USB) WAIT UNTIL THE LED ON THE USB STOPS BLINKING. REMOVAL OF THE USB WHILE THE LED IS STILL BLINKING MAY LEAD TO DATA LOSS OR DAMAGE TO THE PLANNING FILE. IT IS RECOMMENDED TO USE ONLY THE REMOVABLE DISK (USB) THAT IS SUPPLIED WITH THE SUPERDIMENSION INREACH 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 CT IMAGES WERE NOT SHOWING UP ON THE NAVIGATION SCREEN ONCE REGISTRATION WAS COMPLETE. THE PHYSICIAN TRIED RE-EXPORTING THE PLANNING FILE TWICE WITH THE SAME RESULT. THE VIRTUAL SCREEN SHOTS FOR REGISTRATION APPEARED WITHOUT ISSUE. THE SITE REPLACED THE LOCATABLE GUIDE IN TROUBLESHOOTING, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THEREFORE, THE CASE HAD TO BE 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.

    Patients

    Seq Age Sex Outcome Treatment
    1