BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1558266 · Received December 2, 2009

    Report

    Report Number
    2954704-2009-00018
    Event Type
    Other
    Date Received
    December 2, 2009
    Date of Event
    November 5, 2009
    Report Date
    November 5, 2009
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. PHILIPS IS ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. BASED ON THE AVAILABLE ON THE AVAILABLE INFORMATION AT THE TIME OF THIS REPORT, WE CANNOT CONFIRM THAT THE DEVICE WAS A FACTOR IN THE INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED IMPLEMENTING A NEW RIS AND NOTICED AT LEAST 3 INSTANCES OF PATIENT IMAGES WITH INCORRECT DEMOGRAPHICS.

    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