BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 1993612 · Received January 6, 2011

    Report

    Report Number
    3004962788-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 6, 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

    A SITE VISIT WAS PERFORMED ON (B)(4), 2010. THE SERVICE REPORT FOR THIS VISIT STATED THAT THERE WAS A FAILURE OF THE LOCATION BOARD CABLE (LB CABLE) RESULTING FROM MISUSE. AS A RESULT, THE LB CABLE CAUSED DAMAGE TO THE LOCATION SUB SYSTEM (LSS). BOTH THE LSS AND THE LB CABLE WERE REPLACED AND THERE ARE NO FURTHER ACTIONS REQUIRED AT THIS TIME. 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

    A SITE REPORTED THAT THEY COULD NOT GET THE PT SENSOR TRIPLETT (PST) OR LOCATABLE GUIDE (LG) TO APPEAR IN THE SENSING VOLUME, THE LIGHTS WOULDN'T TURN GREEN. THEY TRIED RESETTING THE LOCATION SUB SYSTEM (LSS), RESTARTING THE SYSTEM AND DISCONNECTING/RECONNECTING CABLES WITH NO CHANGE. THE CASE WAS CANCELLED WITH THE PT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1