BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISITE PACS

    MDR report key: 2103713 · Received May 23, 2011

    Report

    Report Number
    2954704-2011-00005
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    April 24, 2011
    Report Date
    May 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CT WAS TAKEN OF A STROKE PT, BUT THE IMAGES WERE NOT AVAILABLE FOR REVIEW. THIS ISSUE IS STILL UNDER INVESTIGATION FOR CONDITIONS OF USE AND PT CARE.

    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