BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 1731862 · Received June 10, 2010

    Report

    Report Number
    3004962788-2010-00021
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 14, 2010
    Report Date
    June 10, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A SERVICE CALL WAS PERFORMED AT THIS SITE ON (B)(4), 2010. A COMPONENT OF THE SYSTEM, THE UNION, WAS REPLACED. THE UNION WAS RETURNED FOR ANALYSIS AND THE REPORT SHOWED THAT THE LOCATION BOARD CONNECTOR ON THE UNION WAS CRACKED WHICH LED TO INTERMITTENT ELECTRICAL CONNECTION. THERE WAS NO INJURY TO THE PATIENT REPORTED. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED DUE TO THE ADD'L POTENTIAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCATION BOARD, A COMPONENT OF THE SUPERDIMENSION SYSTEM, WOULD NOT CONNECT TO THE SYSTEM. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PT 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 INREACH BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION INC. I5102045

    Patients

    Seq Age Sex Outcome Treatment
    1