BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 1984733 · Received January 27, 2011

    Report

    Report Number
    2954704-2011-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 27, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUME VISION (VIEW FORUM) IS A PART OF THE ISITE PACS SOFTWARE PACKAGE WHICH IS USED WITH GENERAL COMPUTING HARDWARE TO ACQUIRE, STORE, DISTRIBUTE, PROCESS AND DISPLAY IMAGES AND ASSOCIATED DATA THROUGHOUT A CLINICAL ENVIRONMENT. THE MALFUNCTION IS CURRENTLY UNDER DEFECT INVESTIGATION.

    Description of Event or Problem · 1

    WHEN PERFORMING MEASUREMENTS ON A VOLUME VISION IMAGE, CLINICIANS ARE ABLE TO TAKE SNAPSHOTS OF THEIR MEASUREMENTS IN A CAPTURE WINDOW. IF THE CAPTURE WINDOW IS NOT SAVED AND MEASUREMENT CHANGES ARE MADE TO THE ORIGINAL IMAGE, THE MEASUREMENT VALUES IN THE CAPTURE WINDOW WILL BE UPDATED. HOWEVER, THE ASSOCIATED GRAPHICS IN THE CAPTURE WINDOW WILL NOT BE UPDATED. THIS PROBLEM WAS INITIALLY DISCOVERED BY THE PRODUCT DEVELOPMENT TEAM WHILE PERFORMING TESTING OF THE NEXT VERSION OF VOLUME VISION 8.2. WHEN INVESTIGATED, IT WAS DETERMINED TO ALSO BE PRESENTED IN THE CURRENT DISTRIBUTED PRODUCT (VOLUME VISION 7.4). IT WAS BROUGHT TO THE MFR'S ATTENTION ON (B)(6), 2010. IT WAS LATER REPORTED IN A CUSTOMER COMPLAINT; COMPLAINT WAS RECEIVED ON (B)(6), 2011.

    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 Required Intervention