BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTBANK II

    MDR report key: 2118496 · Received May 26, 2011

    Report

    Report Number
    1058332-2011-00001
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    May 19, 2011
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    MMH
    Removal / Correction Number
    1058332-05/20/2011-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLIENT REPORTED THE PRODUCT MALFUNCTION ON SOFTBANK II VERSION 23.2.0.4 WITH SOFTSCAPE GUI VERSION 1.2.0.15. AFFECTED PRODUCTS INCLUDE ANY VERSION OF SOFTBANK II USING SOFTSCAPE GUI VERSIONS: 1.2.0.0 - 1.2.0.15 AND 1.3.0.4 - 1.3.0.5. METHOD: INSPECTED SOURCE CODE OF PROGRAM.

    Description of Event or Problem · 1

    WHEN IN ORDER ENTRY OR MODIFY WINDOW, IN THE UNLIKELY EVENT THAT A USER CLICKS ON THE GRID HEADER INSTEAD OF DIRECTLY CLICKING ON THE CELL THEY WANT TO ACTIVATE, THERE IS NO VALIDATION PERFORMED ON THE FIELDS. THIS COULD CAUSE REQUIRED FIELDS OR DEFAULTS NOT TO DISPLAY OR BE SAVED ON THE ORDER. IF THIS TAKES PLACE AND THE CROSSMATCH TEST IS ABSENT FROM THE RED BLOOD CELL PRODUCT ORDER, THE PT COULD BE TRANSFUSED WITH BLOOD THAT HAS NOT HAD COMPATIBILITY TESTING PERFORMED IF THE USER DOES NOT NOTICE THE INAPPROPRIATE CROSSMATCH TEST STATUS ON THE TRANSFUSION SLIP OR CROSSMATCH LABEL. NO ADVERSE PT EVENT IS ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTBANK II MMH SCC SOFT COMPUTER

    Patients

    Seq Age Sex Outcome Treatment
    1