BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAVISUAL

    MDR report key: 758798 · Received October 21, 2005

    Report

    Report Number
    2135350-2005-00004
    Event Type
    Other
    Date Received
    October 21, 2005
    Date of Event
    September 8, 2005
    Report Date
    October 20, 2005
    Manufacturer
    EMAGEON INC.
    Product Code
    LLZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A CUSTOMER CALLED IN ON 9/8/06 AND INDICATED THAT IMAGES WERE "FLIPPING" TOP TO BOTTOM IN THE SOFTWARE. REGULATORY AFFAIRS REVIEWED THE CALL ON 9/10/05 AND ESCALATED THE CALL THROUGH THE SERVICES GROUP TO ENGINEERING FOR INVESTIGATION TO VALIDATE THAT ONLY THE IMAGE WAS FLIPPING AND TO VERIFY THAT ORIENTATION LABELS WERE CORRECT. DURING THE TIME WHEN THE CALL WAS ASSIGNED FOR INVESTIGATION, THE SAME ANOMALY WAS UNCOVERED DURING INTERNAL VERIFICATION ACTIVITIES BY A QUALITY ASSURANCE ENGINEER. REGULATORY AFFAIRS REVIEWED THE ANOMALY AND ESCALATED DIRECTLY TO ENGINEERING FOR REVIEW AND ROOT CAUSE ANALYSIS. BY THE TIME IT WAS DETERMINED THAT THE ANOMALY WAS CAUSING INCORRECT ORIENTATION LABELS TO BE DISPLAYED ON THE DATA SET TYPE DESCRIBED IN SECTION B.5., THE 30 DAY REPORTING REQUIREMENT TIMEFRAME HAD EXPIRED. IN ADDITION, FURTHER INVESTIGATION OF THE ISSUE REVEALED THAT SOME MODALITY VENDORS ARE HANDLING THE DICOM STANDARD INCORRECTLY SO THE SOFTWARE IS SIMPLY DISPLAYING THE DATA THAT IS COMING OVER FROM THE THIRD PARTY MODALITY. AS A REPAIR, OUR SOFTWARE WILL NO LONGER ALLOW THE DISPLAY OF ORIENTATION LABELS FOR THESE TYPES OF IMAGE SETS.

    Description of Event or Problem · 1

    ANOMALY DESCRIPTION: ON MULTIFAME NUCLEAR DATA SETS CONTAINING TOMOGRAPHIC ROTATIONS (AS EACH FRAME IS SCROLLED THE ORIENTATION ROTATES AROUND A HEAD-TO-TOE AXIS), OUR SOFTWARE DOES NOT PROPERLY UPDATE THE ORIENTATION LABELS TO REFLECT THE ROTATIONS FROM ONE FRAME TO THE NEXT. THESE ORIENTATION REPORTING ERRORS SHOULD BE APPARENT TO THE USER AS THE ORIENTATION LABELS DO NOT CHANGE EVEN THOUGH THE IMAGES ARE OBVIOUSLY ROTATING IN SPACE DURING SCROLLING THROUGH EACH FRAME. HOW TO IDENTIFY ANOMALOUS IMAGES: WHEN DATA SETS HAVE BEEN AFFECTED BY THE AFOREMENTIONED ANOMALY, THE SPACING BETWEEN SLICES (0018,0088) DICOM TAG IS NOT PRESENT (IT WILL SHOW A VALUE OF 0 IF ADDED AS A VIEWPORT LABEL) AND A ROTATION INFORMATION SEQUENCE (0054,0052) DICOM TAG IS PRESENT. IF THE SPACING BETWEEN SLICES TAG IS PRESENT AND THERE IS NO ROTATIONAL INFO SEQUENCE TAG , THE IMAGE IS NOT ANOMALOUS. IMAGES NOT IMPACTED BY THE ANOMALY. ON MULTIFRAME NUCLEAR DATA SETS WHERE THE ORIENTATION IS CONSTANT FROM ONE FRAME TO THE NEXT (E.G., A SET OF RAMES IN AN AXIAL ORIENTATION), THE ORIENTATION LABELS ARE CORRECT, AND THE ANOMALY IS NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVISUAL MEDICAL IMAGE MANAGEMENT DEVICE LLZ EMAGEON INC. 5.10.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other