BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1421699 · Received May 26, 2009

    Report

    Report Number
    2954704-2009-00005
    Event Type
    Other
    Date Received
    May 26, 2009
    Date of Event
    April 27, 2009
    Report Date
    April 27, 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 IS A MULTIPLE ORGANIZATION (MULTI-ORG) CONFIGURATION USING ONE ARCHIVE. THEIR DICTATION SYSTEM QUERIES THE ARCHIVE FOR EXAMS BASED ONLY ON EXAM ACCESSION (ACC) NUMBER. ACC NUMBERS ARE UNIQUE WITHIN A GIVEN ORGANIZATION FOR A GIVEN EXAM, BUT THE SAME ACC NUMBER MAY BE USED IN ANOTHER ORGANIZATION. IF THE USER QUERIES BY ACC NUMBER FROM WITHIN THE ISITE PACS APPLICATION, ISITE PACS ALSO PROVIDES AND ORG ID TO THE ARCHIVE, SO THAT THE CORRECT EXAM IS RETURNED. IN THIS CASE, THE SITE WAS QUERYING FROM WITHIN THEIR DICTATION SYSTEM FOR AN EXAM USING ONLY THE ACC NUMBER. IF MULTIPLE EXAMS EXIST WITH THE ACC NUMBER, THE DICTATION SYSTEM IS OPENING THE FIRST EXAM RETURNED. WORK AROUND PROVIDED TO CUSTOMER, INSTRUCTED TO QUERY FOR EXAMS FROM WITHIN ISITE PACS APPLICATION. HEALTH RISK ASSESSMENT INDICATED THIS IS HIGHLY DETECTABLE: RETURNED EXAM IS OF DIFFERENT TYPE THAN THE REPORT/DICTATION WORKLIST INDICATES, I.E. REPORT REFERENCES US, BUT RETURNED EXAM IS CT. REPORT/WORKLIST AND RETURNED EXAM SHOW OBVIOUS MISMATCH. PT DEMOGRAPHIC INFO IN THE REPORT/WORKLIST AND THE EXAM DO NOT MATCH. DICTATION SYSTEM QUERY BEING CHANGED TO INCLUDE MRN AND ACC#.

    Description of Event or Problem · 1

    NO REPORT OF PT HARM OR INJURY RELATED TO THIS EVENT. IMMEDIATELY FOLLOWING AN UPGRADE, THE CUSTOMER REPORTED THAT WHEN USING THIRD PARTY DICTATION WORKLIST TO QUERY FOR IMAGES IN ISITE PACS, INCORRECT IMAGES SOMETIMES RETURNED.

    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