BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1421714 · Received July 24, 2009

    Report

    Report Number
    2954704-2009-00014
    Event Type
    Other
    Date Received
    July 24, 2009
    Date of Event
    June 25, 2009
    Report Date
    June 26, 2009
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. WE ARE ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. CUSTOMER REPORTED THAT A PT HAD TO BE BROUGHT BACK TO THE HOSPITAL, BUT HAS NOT PROVIDED ANY ADDITIONAL PT INFO OR DETAILS AS TO ALLEGED CRITICAL FINDING OR PT IMPACT DUE TO FINDING. PT OUTCOME SHOULD NOT DIFFER DUE TO DISPLAY OF IMAGES IN DIFFERENT PACS DEVICES. UNKNOWN WHY HOSPITAL WOULD DISCHARGE WITHOUT CONFIRMATION FROM RADIOLOGY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT HAD A STUDY PERFORMED AND BECAUSE THE IMAGES WERE NOT YET AVAILABLE IN ISITE PACS, THE REFERRING PHYSICIANS USED THIRD PARTY PACS (RUNNING IN PARALLEL TO ISITE PACS) TO REVIEW THE IMAGES, AFTER WHICH THEY SENT THE PT HOME. ONCE THE STUDY WAS AVAILABLE IN ISITE PACS, RADIOLOGISTS IDENTIFIED ALLEGED CRITICAL FINDING AND HAD TO CALL THE PT BACK TO THE HOSPITAL AFTER PREVIOUSLY BEING SENT THEM HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE PACS ISITE PACS LLZ PHILIPS HEALTHCARE INFORMATICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK