BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1241963 · Received September 4, 2008

    Report

    Report Number
    3004962788-2008-00016
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 4, 2008
    Manufacturer
    *
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE SUPERDIMENSION SYSTEM, IT WOULD "FREEZE UP". THE SYSTEM WAS POWERED DOWN AND RE-STARTED AND WITHIN A SHORT TIME, IT FROZE UP AGAIN. IT WAS NOTICED THAT THE PC LIGHTS WERE NOT LIT AND THE USER COULD NOT GET THE PC TO POWER UP OR DOWN. THE CASE COULD NOT BE COMPLETED USING THE SUPERDIMENSION SYSTEM. THE CASE WAS COMPLETED USING FLUOROSCOPY AND SAMPLES WERE OBTAINED. THERE WAS NO HARM OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK * * S490075

    Patients

    Seq Age Sex Outcome Treatment
    1 *