BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTPATH

    MDR report key: 686935 · Received March 13, 2006

    Report

    Report Number
    1058332-2006-00016
    Event Type
    Malfunction
    Date Received
    March 13, 2006
    Report Date
    March 9, 2006
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    LNX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ISSUE HAS BEEN IDENTIFIED IN SIGN OUT ENTRY DURING INTERNAL SOFTWARE TESTING IN VERSION 4.2.1.14. A CASE REPORT WAS COMPLETED AND A TEMPORARY DOCUMENT WAS CREATED FOR THE CASE. THE FINAL DOCUMENT THEN DISPLAYED IN THE SIGN OUT OPTION FOR FINAL SIGNATURE, HOWEVER, THE TEMPORARY DOCUMENT WAS ACTUALLY SIGNED OUT AND AVAILABLE FOR PRINTING AS THE FINAL SIGNED OUT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTPATH LABORATORY INFORMATION SOFTWARE LNX SCC SOFT COMPUTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA