BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 1930315 · Received November 18, 2010

    Report

    Report Number
    3004962788-2010-00042
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPONENT OF THE SYSTEM (THE LOCATABLE GUIDE) WAS RETURNED TO SUPERDIMENSION FOR EVAL. THE ANALYSIS FOUND THAT THE LOCATABLE GUIDE IS FUNCTIONING AS DESIGNED. 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 EXPOSURE TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE HAD A CASE IN WHICH THE SOFTWARE STATED THAT THE LOCATABLE GUIDE (LG) WAS NOT DETECTED. THE SITE REPORTED THAT THE STATUS OF THE LOCATABLE GUIDE WAS ORANGE AND NOT GREEN AS IT SHOULD HAVE BEEN. A RESET OF THE SYSTEM WAS PERFORMED AND A NEW PROCEDURE WAS TRIED. IN ADDITION, THE LOCATABLE GUIDE CABLE WAS REPLACED. HOWEVER, THE SAME MESSAGE APPEARED. THEREFORE, THE PHYSICIAN CHOSE NOT TO COMPLETE THE CASE USING THE SUPERDIMENSION SYSTEM 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