BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 2576468 · Received July 23, 2010

    Report

    Report Number
    2954704-2010-00008
    Event Type
    Other
    Date Received
    July 23, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    PHILIPS HEALTHCARE INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 INFO 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 ADD'L INFO REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MULTIPLE INCORRECT PT RECORD MERGES WERE AUTOMATICALLY OCCURRING IN ISITE PACS. THE REPORTED PT RECORDS ARE CORRECT IN THE RADIOLOGY INFO SYSTEM (RIS). THE CUSTOMER IDENTIFIED THE ERROR IMMEDIATELY DURING REVIEW OF THE IMAGES IN ISITE PACS. SINCE THIS EVENT WAS DUE TO INCORRECT HL7 MAPPING, IT IS SITE SPECIFIC AND WE ARE WORKING WITH OUR RIS/HL7 PARTNERS TO CORRECT THIS. THERE WAS NO REPORT OF HARM OR MISDIAGNOSIS OR DELAY IN TREATMENT DUE TO THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1