BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1230787 · Received November 5, 2008

    Report

    Report Number
    3004962788-2008-00025
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 6, 2008
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL FIELD SPECIALIST WENT TO THE SITE TO CHECK THE SYSTEM IN 2008. IT WAS DISCOVERED THAT THE SITE WAS USING A METAL TRAY NEAR THE LOCATION BOARD AND THIS CAN BE A POTENTIAL CAUSE OF THE REPORTED SYSTEM INACCURACIES. IT WAS RECOMMENDED TO THE SITE TO KEEP METAL TRAYS AND OTHER METAL OBJECTS AWAY FROM THE SENSING VOLUME DURING A CASE. CURRENT LABELING STATES: SIGNIFICANT CHANGES TO THE CONFIGURATION OF THE BRONCHOSCOPY SUITE, INCLUDING INTRODUCTION OF NEW METALLIC EQUIPMENT OR MOVEMENT OF EXISTING METALLIC EQUIPMENT CAN AFFECT THE ACCURACY OF THE SYSTEM". ADDITIONALLY, TWO COMPONENTS OF THE SUPERDIMENSION SYSTEM, A PATIENT SENSOR TRIPLET AND A LOCATION BOARD WERE EXCHANGED AS A PRECAUTIONARY MEASURE. THE SYSTEM WAS THEN CHECKED FOR ACCURACY AND THE RESULTS WERE WITHIN SPECIFICATION. AFTER THE SERVICE ON THE SAME DAY, THE SITE PERFORMED A CASE AND WAS ABLE TO REGISTER THE PATIENT AND THE SYSTEM FUNCTIONED APPROPRIATELY. BOTH THE LOCATION BOARD AND THE PATIENT SENSOR TRIPLET THAT WERE REPLACED WERE ANALYZED AND BOTH WERE FOUND TO BE WITHIN SPECIFICATIONS AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE SYSTEM THEY WERE UNABLE TO REGISTER THE PATIENT. THE SYSTEM WOULD ONLY GIVE "POINTS MISMATCHED" ERRORS. THE SITE REPLACED THE LOCATABLE GUIDE IN AN ATTEMPT TO REGISTER THE PATIENT, BUT THIS ATTEMPT WAS UNSUCCESSFUL. THE SITE WAS UNABLE TO COMPLETE THE CASE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    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