BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIRIS MEDICAL DEVICE DATA SYSTEM

    MDR report key: 3772378 · Received March 10, 2014

    Report

    Report Number
    2954704-2014-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Report Date
    February 12, 2014
    Manufacturer
    PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PHYSICIAN DICTATED A REPORT ON A PT IN XIRIS (RADIOLOGY INFO SYSTEM) WHILE VIEWING IMAGES FOR DIFFERENT PT IN ISITE PACS. XIRIS AND ISITE PACS ARE USED IN CONJUNCTION WITH ONE ANOTHER TO DICTATE REPORTS IN XIRIS ON IMAGED VIEWED IN ISITE PACS. THERE WAS NO REPORT OF PT HARM OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143724 XIRIS MEDICAL DEVICE DATA SYSTEM LLZ PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS 835605

    Patients

    Seq Age Sex Outcome Treatment
    1