BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1421706 · Received May 26, 2009

    Report

    Report Number
    2954704-2009-00006
    Event Type
    Other
    Date Received
    May 26, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 1, 2009
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. CUSTOMER IDENTIFIED THE ISSUE WHILE USING ISITE PACS TO VIEW THE IMAGES AND MPRS FROM THE MODALITY. THIRD PARTY MODALITY ISSUE. FOR MULTI-PLANAR REFORMATIONS (MPR) AUTOMATICALLY GENERATED BY THIRD PARTY MODALITY AFTER ACQUIRING IMAGES WITH A GANTRY TILT, THE SCOUTLINES ON THE REFORMATIONS DO NOT ALIGN CORRECTLY TO ORIGINAL AXIAL SERIES AND SCOUT. IF CUSTOMER MANUALLY GENERATES AN MPR FROM THE MODALITY, SCOUTLINES ARE WORKING CORRECTLY. CUSTOMER INSTRUCTED TO ESCALATE TO THEIR MODALITY VENDOR.

    Description of Event or Problem · 1

    NO REPORT OF PT HARM OR INJURY RELATED TO THIS EVENT. CUSTOMER REPORTED SCOUTLINES NOT MATCHING.

    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 NA