BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOCASE

    MDR report key: 5337400 · Received December 30, 2015

    Report

    Report Number
    2183926-2015-00013
    Event Type
    Malfunction
    Date Received
    December 30, 2015
    Date of Event
    March 13, 2012
    Report Date
    December 30, 2015
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K022881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETROSPECTIVE REVIEW THE ISSUE WAS DETERMINED TO BE REPORTABLE AS A MDR. NOTE THIS ISSUE DOES NOT IMPACT ANY CUSTOMERS IN THE U.S.

    Description of Event or Problem · 1

    MERGE ORTHOCASE DISPLAYS MEDICAL IMAGES FOR DIAGNOSTIC REVIEW. A PROBLEM WAS OBSERVED IN-HOUSE, WHERE ORIENTATION LABELS ARE NOT READ FROM DICOM FILE AND A DEFAULT ORIENTATION IS ASSUMED IN PLUG IN MODE. WHEN ORTHOCASE IS LAUNCHED IN PLUG IN MODE, ORIENTATION LABELS DISPLAYED IN THE VIEWER MAY BE INCORRECT (I.E. SHOW A DEFAULT VALUE). SAVED DATA (E.G. SECONDARY CAPTURE IMAGES) WILL HAVE THE INCORRECT LABELS BURNED IN. THIS ISSUE DOES NOT OCCUR IN STAND-ALONE MODE. THERE IS NO WORK AROUND. THE ORIENTATION LABELS CANNOT BE DISABLED THROUGH CONFIGURATION. THE ISSUE WAS ENCOUNTERED DURING INTEGRATION TESTING WITH ANOTHER PRODUCT. IN MOST CASES, SURGEONS AND PHYSICIANS WOULD USE OF LEAD MARKERS ON THE IMAGES. THE MARKERS WOULD IDENTIFY ORIENTATION OF THE IMAGE AND ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859641 ORTHOCASE SYSTEM ,IMAGE PROCESSING, RADIOLOGICAL LLZ MERGE HEALTHCARE 3.5.1

    Patients

    Seq Age Sex Outcome Treatment
    1