BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT PATH

    MDR report key: 499399 · Received November 19, 2003

    Report

    Report Number
    MW1030293
    Event Type
    Injury
    Date Received
    November 19, 2003
    Date of Event
    October 15, 2003
    Report Date
    November 19, 2003
    Manufacturer
    SOFT COMPUTER CONSULTANTS
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTER IDENTIFIED VIA A ROUTINE UTILITY RUN PATHOLOGY REPORTS THAT HAD NOT PRINTED AND BEEN SENT TO PHYSICIANS. SUBSEQUENT INVESTIGATION HAS REVEALED ADDITIONAL CASES. THE VENDOR HAS BEEN MADE AWARE. ISSUES IDENTIFIED THUS FAR INCLUDE THE ABILITY OF THE SYSTEM TO IDENTIFY PENDING CASES TO PRINT IF THERE ARE MORE THAN 10,000 CASES IN THE SEARCH ALGORITHM, UPON INVESTIGATION OF THIS ISSUE REPORTER FOUND THAT THE SYSTEM WAS LIMITED TO TRACKING CASES ONLY WITHIN THE LAST 2 DAYS, RESTRICTING ABILITY TO DIAGNOSE THIS TYPE OF SYSTEM PROBLEM. THERE IS NO MECHANISM IN THE SYSTEM OR OFFERED BY THE VENDOR TO PROPERLY IDENTIFY ALL CASES NOT PRINTED VIA THE AUTOMATED PRINT SERVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT PATH COMPUTER HARDWARE/SOFTWARE LNX SOFT COMPUTER CONSULTANTS SOFT PATH *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention