BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AYCAN OSIRIX

    MDR report key: 3697254 · Received February 4, 2014

    Report

    Report Number
    3003895711-2014-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Report Date
    January 31, 2014
    Manufacturer
    AYCAN DIGITALSYSTEME GMBH
    Product Code
    LLZ
    PMA / PMN Number
    K103546
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTIONS: AN UPDATE FOR THE SOFTWARE AYCAN OSIRIX WAS CREATED WHICH COVERS THE PROBLEM. ALL USERS ARE INFORMED ABOUT THE PROBLEM AND THE UPDATE. (B)(4).

    Description of Event or Problem · 1

    WHEN DICOM IMAGES ARE VISUALIZED WITH AYCAN OSIRIX WHERE ONE DICOM FILE CONTAINS IMAGE DATA WITH AREAS OF DIFFERENT RESOLUTION VALUES (E.G. TWO AREAS OF DIFFERENT RESOLUTION VALUES - WHICH IS DIFFERENT TO THE 'TYPICAL' DICOM DATASET), WHILE DOING E.G. LENGTH DETERMINATION/CALCULATION THE SOFTWARE DOES NOT RECOGNIZE MORE THAN 1 RESOLUTION VALUES PER IMAGE, WHICH MIGHT RESULT IN INCORRECT LENGTH ETC. DETERMINATION/CALCULATION. 'TYPICAL' DICOM DATASETS USE ONLY ONE RESOLUTION PER IMAGE/FILE AND THE RESOLUTION IS CONSISTENT THROUGHOUT THE WHOLE SERIES. IMAGES WITH DIFFERENT RESOLUTIONS IN ONE FILE HAPPEN TO BE ULTRASOUND IMAGES WHERE, DURING TYPICAL WORKFLOW, MEASUREMENTS ARE USUALLY DONE DIRECTLY AT THE MODALITY DURING ACQUISITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73559 AYCAN OSIRIX PICTURE ARCHIVING AND COMMUNICATIONS LLZ AYCAN DIGITALSYSTEME GMBH VERSION<=2.08.002

    Patients

    Seq Age Sex Outcome Treatment
    1