BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTBANK II

    MDR report key: 2308754 · Received September 27, 2011

    Report

    Report Number
    1058332-2011-00004
    Event Type
    Malfunction
    Date Received
    September 27, 2011
    Report Date
    September 16, 2011
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    MMH
    Removal / Correction Number
    1058332-09/16/2011-011-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RE: THE CLIENT REPORTED THE PRODUCT MALFUNCTION ON SOFTBANK II VERSION 25.1.0.2. AFFECTED PRODUCTS INCLUDE SOFTBANK II VERSIONS 23.2.0.1-23.2.0.5, 25.0.0.3-25.0.0.5, 25.1.0.1-25.1.0.2.

    Description of Event or Problem · 1

    WHEN PRINTING AN ISBT LABEL FOR A BLOOD PRODUCT WITH AN EXPIRATION TIME OF MIDNIGHT (00:00), THE GENERATED LABEL PRINTS 23:59 INSTEAD AS THE EXPIRATION TIME IN THE BARCODE. THE UNIT CAN BE MISLABELED WITH A FALSELY EXTENDED EXPIRATION TIME. 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