BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT PATH

    MDR report key: 703933 · Received April 20, 2006

    Report

    Report Number
    1058332-2006-00018
    Event Type
    Malfunction
    Date Received
    April 20, 2006
    Report Date
    January 17, 2001
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A SECOND EVENT OF A REPORTED FAILURE. THIS IS THE SAME FAILURE AS UNCH-01378. THE CLIENT HAD MADE A DECISION TO USE THE SOFTPATH MODULE IN A NONSTANDARD MANNER. THE CLIENT WOULD, ON CERTAIN CASES, REGISTER AND PROCESS THE CASE AND THEN SIGN OUT THE CASE WITHOUT ENTERING ANY TYPE OF RESULTS. THEREFORE A FINAL REPORT HAD NO DIAGNOSIS TEXT. LATER THE CLIENT CREATED A SUPPLEMENTAL REPORT TO ISSUE DIAGNOSTIC INFORMATION. IMMEDIATELY AFTER CREATING THIS REPORT THE USER ACCESSES THE "CREATE NEW" SELECTION IN THIS OPTION FOR ANOTHER CASE. THE SYSTEM THEN CREATED A "FINAL" DOCUMENT FOR THE CURRENT CASE AND THE TEXT FROM THE PREVIOUSLY PRINTED CASE FOR ANOTHER PATIENT IS SAVED FOR THIS PATIENT. THIS ANOMALY OCCURS FOR TWO REASONS: 1. THE "FINAL REPORT" WAS NOT CREATED AS THE SYSTEM EXPECTED. 2. THE TEMPORARY DIRECTORY THAT IS CREATED DURING THE "PRINT PENDING" OPERATION IS NOT CLEARED UNTIL EXITING TO THE MAIN MENU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT PATH LABORATORY INFORMATION SYSTEM LNX SCC SOFT COMPUTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *