BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2132489 · Received June 17, 2011

    Report

    Report Number
    3004962788-2011-00029
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 17, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANALYSIS OF THE PROCEDURE RECORDING AND MAINTENANCE LOG IS PENDING. A FUNCTIONAL TEST WAS PERFORMED BY A COMPANY REPRESENTATIVE ON (B)(4) 2011 AND THE SYSTEM PERFORMED NORMALLY. 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. NO RETURN.

    Additional Manufacturer Narrative · 1

    A COPY OF THE RECORDING FROM THIS CASE WAS RECEIVED FOR ANALYSIS AS WELL AS THE MAINTENANCE LOGS. THE ANALYSIS STATED THAT A POTENTIAL ROOT CAUSE WAS IDENTIFIED IN THE SOFTWARE AND WAS FIXED SUCH THAT RAPID MULTIPLE "START" EVENTS ARE IGNORED. THIS FIX WILL BE MADE AVAILABLE WITH THE NEXT SOFTWARE RELEASE. HARDWARE INPUT DEVICES (E.G. KEYBOARD, MOUSE, FOOTSWITCH) WERE ALSO EVALUATED IN-HOUSE AND THE ERROR WAS NOT REPRODUCIBLE. THE SITE HAS PERFORMED AT LEAST 6 CASES AFTER THIS EVENT WITHOUT ANY FURTHER REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEY HAD REGISTERED THE PATIENT AND WHEN THEY WENT TO NAVIGATION, THEY RECEIVED ERROR #284 ON THE SCREEN STATING "A SYSTEM ERROR HAS OCCURRED. PRESS IGNORE TO CONTINUE. IF PROBLEM PERSISTS, PLEASE CALL SERVICE." THEY CLICKED IGNORE AND THE SCREEN FROZE. THEY WERE NOT ABLE TO CONTINUE THE PROCEDURE. THEREFORE, THE CASE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA.

    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