BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 13017666 · Received December 16, 2021

    Report

    Report Number
    9615916-2021-00003
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 16, 2021
    Manufacturer
    INTELERAD MEDICAL SYSTEMS INC.
    Product Code
    LLZ
    UDI-DI
    B228INTELEPACS0
    PMA / PMN Number
    K192176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    WHEN USING ADVANCED VISUALISATION TO RECONSTRUCT MR, CT AND PET IMAGES THAT CONTAIN NON-SQUARE PIXELS, THE RECONSTRUCTED IMAGE IS INCORRECT. NON-SQUARE PIXELS OCCUR WHEN THE ROW AND COLUMN PIXEL SPACING VALUES ARE DIFFERENT. MEASUREMENTS MADE ON THIS IMAGE ARE ALSO CONSEQUENTLY ERRONEOUS. THIS ISSUE DOES NOT AFFECT MEASUREMENTS MADE ON REGULAR 2D VIEWS. WHEN USING ADVANCED VISUALISATION IN THE ENHANCED VIEWER TO RECONSTRUCT MR AND CT IMAGES THAT HAVE NON-ORTHOGONAL VOLUME AXES (E.G. GANTRY TILT), LINEAR MEASUREMENTS WILL BE INCORRECT DUE TO THE USE OF AN INCORRECT FORMULA. THIS ONLY OCCURS FOR MEASUREMENTS MADE ON A RE-ORIENTED VIEW (E.G. MPR). INTELEVIEWER CAN BE AFFECTED WHEN USING THE EV ADVANCED VISUALISATION VIEW EMBEDDED INSIDE INTELEVIEWER (INTELEVIEWER VERSIONS 5.4.1.R1 AND LATER). HAZARD INVOLVED: WHEN THE SPECIFIC CIRCUMSTANCES DESCRIBED ABOVE OCCUR, THERE IS A POSSIBILITY OF DISPLAYING DISTORTED IMAGES ALONG WITH ERRONEOUS MEASUREMENTS. THE DISTORTION AND MEASUREMENT DIFFERENCE COULD AFFECT DECISIONS REGARDING PATIENT CARE. FOR ISSUE 1, THE MAXIMUM MEASUREMENT ERROR IS PROPORTIONAL TO THE RATIO OF ROW AND COLUMN PIXEL SPACINGS. NO PATIENT HARM HAS BEEN REPORTED AT THIS TIME. THIS IS MERELY A PRECAUTIONARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919765 INTELEPACS INTELEPACS LLZ INTELERAD MEDICAL SYSTEMS INC. ENHANCED VIEWER 1.17.4 TO 1.19.19 AND INTELEVIEWER 4-3-1 R1 TO 5-4-1 B228INTELEPACS0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown