BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 1722242 · Received June 3, 2010

    Report

    Report Number
    3004962788-2010-00019
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 6, 2010
    Report Date
    June 3, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPERDIMENSION REPRESENTATIVE WENT TO THE SITE TO EVALUATE THE SYSTEM AND IT WAS DISCOVERED THAT THE MOUSE THAT WAS BEING USED WAS NOT THE MOUSE THAT WAS INITIALLY INSTALLED WITH THE SYSTEM. THE MOUSE THAT WAS BEING USED WAS INCOMPATIBLE WITH THE PC. THE CASE WAS NOT COMPLETED WITH THE SUPERDIMENSION SYSTEM WITH THE PATIENT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PATIENT, BUT IN AN ABUNDANCE OF CAUTION WE ARE FILING THIS MDR BECAUSE OF THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SYSTEM GAVE AN ERROR MESSAGE FROM WINDOWS STATING IT HAD ENCOUNTERED A PROBLEM AND HAD TO BE SHUT DOWN. THE COMPUTER SHUT ITSELF DOWN. THE PHYSICIAN RESTARTED IT AND ENCOUNTERED THE SAME MESSAGE AT THE LOGIN SCREEN. THEY DID A HARD SHUTDOWN AND RESTARTED, AGAIN ENCOUNTERING THE SAME MESSAGE. THE SUPERDIMENSION PORTION OF THE CASE WAS THEN ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1