BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOCASE

    MDR report key: 5437883 · Received February 16, 2016

    Report

    Report Number
    2183926-2015-00127
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    October 2, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K022881
    Removal / Correction Number
    Z-0878-2017; RES 75909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Additional Manufacturer Narrative · 1

    SUBMITTING THIS SUPPLEMENTAL REPORT TO ADD FDA CORRECTION AND REMOVAL REFERENCE NUMBERS.

    Description of Event or Problem · 1

    A MERGE ORTHOCASE CUSTOMER REPORTED THAT THE DISPLAYED VALUE OF THE MEASUREMENT IS CHANGING AFTER SAVING A PLAN WITH A MEASUREMENT RESULT. WHEN USING THE PERPENDICULAR LINE TOOL, THERE IS AN OPTION TO "SNAP" THE LINES TOGETHER, WHICH PREVENTS THE PERPENDICULAR LINES FROM EXTENDING PAST THE STRAIGHT/BASE LINE. THE SYSTEM DEFAULT IS TO SNAP THESE LINES. TO REMOVE THE SNAPPING FUNCTION FROM THE CURRENT ANNOTATION, SIMPLY RIGHT CLICK NEAR THE LINE AND DESELECT "SNAP TO." WHILE THE SYSTEM DEFAULT IS SET TO SNAP THE LINES TOGETHER, THE ACTUAL "SNAP" FUNCTION MAY NOT OCCUR UNTIL THE PLAN IS SAVED, AT WHICH TIME THE LINE END POINT WITHIN 20 PIXELS OF THE BASE LINE WILL ADJUST ITS LOCATION TO SNAP PERFECTLY TO THE BASE LINE. THIS MAY ADJUST THE LENGTH AND CORRESPONDING MEASUREMENT OF THE PERPENDICULAR LINE WHEN THE PLAN IS REOPENED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96172 ORTHOCASE MEDICAL IMAGE PROCESSING SOFTWARE. LLZ MERGE HEALTHCARE 3.7.3

    Patients

    Seq Age Sex Outcome Treatment
    1