BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1321322 · Received February 13, 2009

    Report

    Report Number
    2954704-2009-00002
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    January 22, 2009
    Report Date
    January 22, 2009
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK AT THIS TIME WHETHER THIS IS RELATED TO A PRODUCT MALFUNCTION. THE ISSUE IS NOT REPRODUCIBLE WITH IN-HOUSE TESTING OF THE SAME PRODUCT VERSION. 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.

    Description of Event or Problem · 1

    NO REPORT OF PT HARM OR INJURY RELATED TO THIS EVENT. WE RECEIVED A COMPLAINT FROM A CUSTOMER REPORTING THAT IMAGES AVAILABLE PREVIOUSLY COULD NOT BE FOUND. INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION IS COMPLETE.

    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 NA