BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3670419 · Received February 13, 2014

    Report

    Report Number
    8022257-2014-00001
    Event Type
    Other
    Date Received
    February 13, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY COMPLETED AN INVESTIGATION AND CONCLUDED THAT THE SYSTEM PERFORMED AS DESIGNED. PROTECTIVE MEASURES ARE DESIGNED IN THE SYSTEM, IN THE FORM OF AN ALERT, TO NOTIFY USERS WHEN ONE OR MORE IMAGES IN A STUDY HAVE NOT BEEN REVIEWED PRIOR TO REPORTING THE STUDY. HORIZON MEDICAL IMAGING ALLOWS USERS TO LINK SERIES CONTAINING CROSS-SECTIONAL IMAGES. THIS ENABLES THE USER TO SCROLL THROUGH MULTIPLE SERIES SIMULTANEOUSLY. WHEN THE SERIES ARE LINKED, WHILE THE USER SCROLLS THROUGH THE ACTIVE SERIES, THE CORRESPONDING IMAGES IN THE ASSOCIATED LINKED SERIES ARE DISPLAYED IN THE INACTIVE VIEW PORT. THE CORRESPONDING IMAGE DISPLAYED IS THE CLOSEST ANATOMICAL IMAGE IN THE DIRECTION OF THE SCROLLING. AT THE REPORTING FACILITY, TWO SERIES WERE BEING VIEWED USING THE SCROLLING THROUGH LINKED SERIES FUNCTIONALITY. WHEN SCROLLING FROM THE 3RD TO THE 4TH IMAGE IN THE ACTIVE SERIES THE APPLICATION DISPLAYED IMAGE 3 FOLLOWED BY IMAGE 5 IN THE INACTIVE SERIES. IMAGES DISPLAYED IN THE INACTIVE SERIES ARE BASED ON THE DICOM TAG THAT STORES THE SLICE LOCATION, AND THE DIRECTION OF THE SCROLLING. IMAGE 4 WAS NOT DISPLAYED BECAUSE IT WAS NOT THE CLOSEST ANATOMICAL IMAGE IN THE DIRECTION OF THE SCROLLING. NO FURTHER ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FACILITY WAS VIEWING TWO SERIES OF MRI IMAGES FROM A STUDY IN TWO SEPARATED VIEW-PORTS WITH SCROLLING THROUGH LINKED SERIES ENABLED. IT WAS ALLEGED THAT WHEN THE USER VIEWED THE IMAGES BY SCROLLING THROUGH THE TWO LINKED SERIES, AN IMAGE FROM THE SERIES BEING DISPLAYED IN THE INACTIVE VIEW PORT WAS SKIPPED AND DID NOT GET DISPLAYED. THE SKIPPED IMAGE CONTAINED INFO ABOUT A BRAIN INFARCTION. REPORTING FACILITY HAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95672 HORIZON MEDICAL IMAGING LLZ MCKESSON MEDICAL IMAGING COMPANY 11.5.1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention