BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 2123202 · Received November 18, 2008

    Report

    Report Number
    2954704-2008-00007
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 19, 2008
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO INFORM US THAT MARKING TEXT ADDED TO THE IMAGE AT THE MODALITY AS AN OVERLAY WAS NOT DISPLAYING IN ISITE PACS. NO REPORT OF PT INJURY OR HARM. WE WERE ABLE TO CONFIRM THIS DEFECT, AND THAT IT IS SPECIFIC TO ISITE PACS V 3.5.83 CLIENT. WHILE SYSTEMIC, THIS IS ISOLATE TO ONE CUSTOMER, AS THEY WERE THE FIRST AND ONLY CUSTOMER TO UPGRADE TO THIS SOFTWARE VERSION. CUSTOMER IS AWARE OF THE ISSUE AND WE WORKED WITH THEM TO PROVIDE MITIGATION THROUGH A WORKAROUND UNTIL WHICH TIME THEY CAN BE UPGRADED TO A CORRECTED VERSION. NO FURTHER ACTION REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1