BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1671184 · Received April 26, 2010

    Report

    Report Number
    2954704-2010-00004
    Event Type
    Other
    Date Received
    April 26, 2010
    Date of Event
    April 3, 2010
    Report Date
    April 26, 2010
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    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. BASED ON THE AVAILABLE INFORMATION AT THE TIME OF THIS REPORT, WE CANNOT CONFIRM THAT THE DEVICE WAS A FACTOR IN THE INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE RECEIVED REPORT STATE THAT WHEN OPENING AN EXAM USING THE XIRIS BRIDGE AND ISITE PACS, CUSTOMER IS UNABLE TO SEE ALL IMAGES IN THE ALLOTTED WINDOW.

    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