BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 1480689 · Received July 22, 2009

    Report

    Report Number
    2954704-2009-00012
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    November 8, 2005
    Report Date
    November 8, 2005
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Removal / Correction Number
    7-0399-2006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. PRODUCT CAN BE EVALUATED AT THE CUSTOMER SIDE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. CUSTOMER IDENTIFIED THAT EXAMS FROM TWO DIFFERENT PATIENTS MAY BE SHOWN SIMULTANEOUSLY BETWEEN THE PRESENTATION MONITOR AND THE DIAGNOSTIC DISPLAYS. INVESTIGATION DETERMINED THAT WHEN USING A THIRD PARTY DICTATION DEVICE WITH ISITE PACS, A DEFECT MAY OCCUR WHEN THE TWO APPLICATIONS ARE SENDING MESSAGES BACK AND FORTH AS EXAMS FROM VARIOUS PATIENTS ARE SELECTED IN AN ATTEMPT TO KEEP EACH OTHER SYNCHRONIZED. THE RESULT IS THAT THE EXAM FOR ONE PT SELECTED AND SHOWN ON THE PRESENTATION MONITOR MAY BE DIFFERENT THAN THE EXAM SHOWN ON THE DIAGNOSTIC DISPLAY. RECALL REFERENCE (B)(4) IMPLEMENTED DECEMBER 2005.

    Description of Event or Problem · 1

    NO REPORT OF PT HARM OR INJURY RELATED TO THIS EVENT. CUSTOMER REPORTED THE WORKSTATION IS SHOWING TWO PATIENTS AT THE SAME TIME.

    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