BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 2193459 · Received August 3, 2011

    Report

    Report Number
    2954704-2011-00008
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHILIPS BECAME AWARE OF THIS INCIDENT ON (B)(6), 2011. REFORMATIONS GENERATED ON THE GE WORKSTATION APPEARS TO BE ADDING SOME PIXEL PADDING VALUES CAUSING THE LOCALIZER AND SCOUT LINES TO BE MISALIGNED TO THE CORRESPONDING ANATOMY ON THE ORIGINAL IMAGES. ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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