BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2370403 · Received March 30, 2011

    Report

    Report Number
    3004962788-2011-00011
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 30, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROCEDURE RECORDINGS WERE OBTAINED AND REVIEWED. THE RESULTS SHOWED THE AUTO-REGISTRATION AND VERIFICATION WERE NOT PERFORMED PER THE USER MANUAL INSTRUCTIONS. THERE WAS NO INJURY TO THE PT 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

    THE SITE REPORTED A CASE IN WHICH THEY HAD INACCURACY WHILE NAVIGATING IN THE CENTRAL AIRWAYS. IT CONTINUALLY WOULD SHOW THEM OUT OF THE AIRWAY EVEN AFTER MULTI-PLE REGISTRATION ATTEMPTS. THE CASE WAS CANCELLED WITH THE PT 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