BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1313803 · Received December 4, 2008

    Report

    Report Number
    3004962788-2008-00029
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    November 7, 2008
    Report Date
    December 4, 2008
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGED THAT THE CT IMAGES LOADED WERE VERY "GRAINY WITH BLACK LINES THROUGH THE SCREEN". THE SITE SWAPPED OUT SEVERAL CABLES IN AN EFFORT TO FIX THE ISSUE, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THEREFORE, THE SITE CANCELLED THE PROCEDURE. THERE WAS NO 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 SUPERDIMENSION, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *