BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 2020507 · Received February 10, 2011

    Report

    Report Number
    3004962788-2011-00007
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 9, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS, AND CONCLUSIONS: A SITE VISIT WAS PERFORMED ON (B)(6) 2011. THE REPORT STATED THAT THERE WAS A FAILURE OF A COMPONENT OF THE SYSTEM, THE LOCATION BOARD CABLE TAIL. THE LOCATION BOARD CABLE TAIL WAS REPLACED AND THE OLD ONE WAS RETURNED FOR ANALYSIS. THE EVALUATION OF THE LOCATION BOARD CABLE TAIL DETERMINED THAT THERE WAS A CABLE CONDUCTOR FRACTURE. THERE WAS NO INJURY TO THE PATIENT 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

    IT WAS REPORTED THAT THE SITE WAS NOT ABLE TO GET THE LOCATION BOARD TO CONNECT PRIOR TO A PROCEDURE. THEY SWAPPED FOR A SPARE LOCATION BOARD CABLE BUT STILL ENCOUNTERED THE SAME PROBLEM. THEREFORE, 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 INREACH BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1