BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALI ULTRAPACS DIAGNOSTIC REPORTING CLIENT SOFTWARE

    MDR report key: 437536 · Received January 9, 2003

    Report

    Report Number
    8022257-2002-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2003
    Report Date
    August 21, 2001
    Manufacturer
    A.L.I. TECHNOLOGIES, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING PROBLEMS WERE DISCOVERED IN VERSION 2.0 OF THE SOFTWARE. 1. IF MULTIPLE REPORTS USING THE SAME TEMPLATE ARE OPENED IN EDIT MODE AT THE SAME TIME, SWITCHING BETWEEN THOSE REPORTS MAY RESULT IN DATA FROM ONE FORM BEING COPIED IN ERROR INTO THE SECOND FORM. INVESTIGATION HAS DETERMINED THAT THIS OCCURS IN FREE-TEXT (I.E. COMMENT) FIELDS ONLY. IT DOES NOT OCCUR IN CALCULATED FIELDS OR TREE FIELDS AND IT DOES NOT OCCUR IN COMMENT FIELDS CONTAINED WITHIN THE TREES. 2. INFORMATION SELECTED FROM NODES LOCATED AT THE FOURTH LEVEL OR DEEPER IN A TREE IS OCCASIONALLY DROPPED (I.E. DATA DISAPPEARS FROM THE REPORT) WHEN A SAVED REPORT IS RE-OPENED IN EDIT MODE. ALL THE DATA ORIGINALLY SELECTED ON THE FIRST SAVE DOES APPEAR ON THE SNAPSHOT IN VIEW MODE. 3. DATA FROM THE LAST FIELD ENTERED ON A REPORT WILL NOT BE SAVED IN THE DATABASE UNLESS THE ENTER KEY OR TAB KEY IS PRESSED BEFORE CLICKING THE SAVE BUTTON. THE DATA IN THIS FIELD DOES APPEAR ON THE SNAPSHOT IN VIEW MODE. 4. WHEN A SNAPSHOT IS PRINTED OR DISPLAYED IN VIEW MODE, DATA IN THE FIRST FIELD AFTER A PAGE BREAK MAY BE MISSING HOWEVER, THE DATA IN THESE FIELDS HAS BEEN SUCCESSFULLY STORED IN THE DATABASE AND WILL BE PRESENT IN EDIT MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALI ULTRAPACS DIAGNOSTIC REPORTING CLIENT SOFTWARE COMPUTERIZED PATIENT REPORT FORM LNX A.L.I. TECHNOLOGIES, INC. CRX 310 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *