BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANGE HEALTHCARE ENTERPRISE VIEWER

    MDR report key: 11488096 · Received March 15, 2021

    Report

    Report Number
    8022257-2021-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 15, 2021
    Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY
    Product Code
    LLZ
    UDI-DI
    17540262010039
    PMA / PMN Number
    K181185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE HEALTHCARE INVESTIGATED THE REPORTED ISSUE AND DETERMINED THERE WAS A SOFTWARE DEFECT IN CHANGE HEALTHCARE ENTERPRISE VIEWER (CHEV). THE PROBLEM OCCURS WHEN A SCHEDULED STUDY EXISTS IN A PACS PATIENT RECORD AND A MORE RECENT PERFORMED STUDY FROM THE SAME PATIENT RECORD IS OPENED IN CHEV. IMAGES FROM THE OPENED (ANCHOR) STUDY ARE DISPLAYED IN THE VIEWPORT BUT THE ANCHOR STUDY DETAILS AND IMAGE THUMBNAILS ARE NOT DISPLAYED ON THE PATIENT TIMELINE. THE MISSING TIMELINE INFORMATION COULD POTENTIALLY LEAD TO A STUDY CONTEXT ERROR.

    Description of Event or Problem · 1

    A NEUROSURGEON INITIALLY MISINTERPRETED ANCHOR IMAGES DISPLAYED IN THE VIEWPORT OF THE CHANGE HEALTHCARE ENTERPRISE VIEWER (CHEV) AS A PRIOR STUDY. IT WAS REPORTED THIS CAUSED THE NEUROSURGEON TO ALMOST USE THE WRONG IMAGE FOR SURGERY. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386944 CHANGE HEALTHCARE ENTERPRISE VIEWER ENTERPRISE VIEWER LLZ CHANGE HEALTHCARE CANADA COMPANY 2.1 17540262010039

    Patients

    Seq Age Sex Outcome Treatment
    1