BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALI WEB GX VERSION 3.0

    MDR report key: 437158 · Received January 9, 2003

    Report

    Report Number
    8022257-2002-00002
    Event Type
    Injury
    Date Received
    January 9, 2003
    Date of Event
    September 6, 2002
    Report Date
    September 10, 2002
    Manufacturer
    A.L.I. TECHNOLOGIES, INC.
    Product Code
    LNX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REVIEWED PATIENT STUDY ON ALI WEBGX VERSION 3.0 IN PREPARATION FOR A SURGICAL PROCEDURE TO DRAIN PATIENT'S SINUS. IMAGES WERE DISPLAYED ON WEBGX THE SAME WAY THEY WERE STORED WHEN CREATED BY THE GENERAL ELECTRIC CT SCANNER (I.E PRONE IMAGES SHOWING RIGHT SIDE OF PATIENT ON THE RIGHT SIDE OF THE WEBGX VIEWPORT). SURGEON ASSUMED IMAGE PRESENTATION WAS THE EXPECTED CLINICAL PRESENTATION (I.E. LEFT SIDE OF PATIENT SHOWN ON RIGHT SIDE OF WEBGX VIEWPORT) AND DID NOT EXAMINE THE LABELING ON THE IMAGE (WHICH SHOWED A "R" MARKER ON THE PATIENT'S RIGHT SIDE). SURGEON PERFORMED A SINUS DRAINING PROCEDURE ON THE INCORRECT SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALI WEB GX VERSION 3.0 WEB-BASED MEDICAL IMAGE VIEWER LNX A.L.I. TECHNOLOGIES, INC. WEBGX VERSION 3.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention