BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1888368 · Received October 19, 2010

    Report

    Report Number
    3004659744-2010-00010
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A SERVICE CALL WAS PERFORMED AT THIS SITE ON (B)(6), 2010. THE SERVICE TECHNICIAN VERIFIED THAT A COMPONENT OF THE SYSTEM, THE LOCATION BOARD (B)(4), WAS NOT FUNCTIONING APPROPRIATELY. THEREFORE THE LOCATION BOARD COMPONENT WAS REPLACED. AFTER REPLACING THE LOCATION BOARD, THE SYSTEM FUNCTIONED APPROPRIATELY. THE LOCATION BOARD WAS RETURNED TO SUPERDIMENSION FOR ANALYSIS. THE ANALYSIS CONFIRMED THAT THERE IS AN INTERMITTENT CONNECTION IN THE LOCATION BOARD CONNECTOR TAIL. THE CASE WAS NOT COMPLETED WITH THE SUPERDIMENSION SYSTEM WITH THE PATIENT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PATIENT, BUT IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MDR BECAUSE OF THE ADD'L RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM GAVE AN ERROR MESSAGE THAT THE LOCATION BOARD WAS NOT DETECTED. THE SITE CHANGED THE LOCATION BOARD CABLE BUT THE ISSUE WAS NOT RESOLVED. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1