BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTBANK II

    MDR report key: 742912 · Received July 24, 2006

    Report

    Report Number
    1058332-2006-00019
    Event Type
    Malfunction
    Date Received
    July 24, 2006
    Date of Event
    June 21, 2006
    Report Date
    June 21, 2006
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTERNATIVE SOLUTION: THE FOLLOWING ALTERNATIVE SOLUTIONS ALLOW CLIENTS TO USE THE SYSTEM WITHOUT BEING AFFECTED BY THIS ISSUE. FOR SOFTBANK CLIENTS WITH VERSIONS 21.4.5, 22.4.2, 23.0.1 OR HIGHER THAN ALTERNATIVE SOLUTION IS TO SET BB PARAMETER HOS_CANCEL_COND TO NOT ALLOW THE CANCELLATION OF COMPLETED TESTS AND/OR LIMIT ACCESS TO THE CANCEL OPTION IN SECURITY. FOR SOFTBANK CLIENTS WITH VERSIONS 19.X, 21.2X 21.4.1, 21.4.2, 21.4.3, 22.4.0, OR 22.4.1 THE ALTERNATIVE SOLUTION IS TO LIMIT ACCESS TO THE CANCEL OPTION IN SECURITY. CORRECTION RECOMMENDATION FOR THE REPORTING CLIENT: CORRECT IN A 23.1.1.X PATCH OR 23.1.2.X PATCH. NOTIFICAION RECOMMENDATION FOR THE REMAINING AFFECTED CLIENT BASE: NOTIFY ALL AFFECTED CLIENTS. CORRECTION RECOMMENDATIONS FOR THE REMANING AFFECTED CLIENT BASE: CORRECT IN A 23.1.2.X PATCH AND IN A 23.1.1.X PATCH.

    Description of Event or Problem · 1

    FOR CLIENTS USING SOFTBANK II, TO CANCEL THE COMPLETED ANTI-BODY IDENTIFICATION TEST THAT WROTE THE ANTI-BODY TO THE PT'S HISTORICAL RECORD, THE SYSTEM WILL REMOVE THE ANTI-BODY IDENTIFIED IN THE CANCELLED ANTI-BODY IDENTIFICATION TEST FROM THE PT'S HISTORICAL RECORD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *