BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1343884 · Received February 19, 2009

    Report

    Report Number
    3004962788-2009-00005
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    January 22, 2009
    Report Date
    February 19, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE PERFORMING A PROCEDURE UNDER GENERAL ANESTHESIA THE SYSTEM WOULD NOT RECOGNIZE THE LOCATABLE GUIDE WITHIN THE SENSING VOLUME. THE SITE PERFORMED TROUBLESHOOTING BY CYCLING THE POWER, SWAPPING THE LOCATABLE GUIDE, SWAPPING THE LOCATABLE GUIDE CABLE, RE-POSITIONING THE PT AND RE-CONNECTING ALL CABLES AND CORDS. THE NURSE THEN WENT INTO ADVANCED MODE (IN THE SUPERDIMENSION SYSTEM) AND THE LG WAS OUTSIDE OF THE SENSING FIELD. THE PHYSICIAN THEN DECIDED TO STOP TROUBLESHOOTING AND CONTINUE THE CASE WITHOUT THE SUPERDIMENSION SYSTEM. THERE WAS NO HARM OR INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *