BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1616818 · Received February 1, 2010

    Report

    Report Number
    2954704-2010-00001
    Event Type
    Other
    Date Received
    February 1, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THERE WAS NO DEATH OR SERIOUS INJURY RELATED TO THIS EVENT. THIS IS A REPORT OF AN ISSUE WITH THIRD PARTY (B)(4) WHEN USED WITH ISITE PACS. (B)(4) IS VOICE RECOGNITION SOFTWARE USED FOR DICTATING DIAGNOSTIC REPORTS FOR EXAMS. THE (B)(4) SOFTWARE HAS SHOWN UNEXPECTED FUNCTIONALITY IN THAT AN UNEXPECTED DATA INPUT WINDOW APPEARS IN ADDITION TO THE ORIGINAL WINDOW, WHICH IS NOT UPDATING AS EXPECTED BY THE USER. PHILIPS IS FURTHER EVALUATING WHETHER THERE IS ANY PATIENT HEALTH RISK.

    Description of Event or Problem · 1

    PHILIPS EMPLOYEE REPORTED THAT CUSTOMER INDICATED THIRD PARTY APPLICATION (B)(4) WINDOW NOT UPDATING WITH EXPECTED PATIENT INFORMATION.

    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