BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANGE HEALTHCARE RADIOLOGY SOLUTIONS

    MDR report key: 10495255 · Received September 4, 2020

    Report

    Report Number
    8022257-2020-00001
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    July 29, 2020
    Report Date
    September 4, 2020
    Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY
    Product Code
    LLZ
    UDI-DI
    17540262030020
    PMA / PMN Number
    K140909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE HEALTHCARE HAS IDENTIFIED A SOFTWARE DEFECT WHICH MAY RESULT IN ONE OR MORE IMAGES/DICOM OBJECTS MISSING FROM A STUDY AFTER IT IS IMPORTED INTO THE PACS. THIS IS CAUSED BY A DISCREPANCY BETWEEN THE IMAGE INDEX AND THE FILES STORED WITHIN THE IMAGE FOLDERS. AS A RESULT OF THIS DISCREPANCY, A USER MAY EXPERIENCE ONE OF THE FOLLOWING SCENARIOS: 1. THE STUDY CANNOT BE OPENED AND AN ERROR MESSAGE IS DISPLAYED, OR 2. THE STUDY CAN BE OPENED AND AN ERROR IS DISPLAYED ON THE VIEWPORT OF THE MISSING IMAGE(S), OR 3. THE STUDY CAN BE OPENED AND NO WARNING MESSAGE IS PRESENTED TO THE USER THAT THERE ARE MISSING IMAGES. THE IMPACTED IMAGE FILES ARE RETAINED IN THE IMAGE FOLDER BUT ARE NOT VISIBLE TO THE USER. WHEN THE STUDY IS ARCHIVED, THESE IMPACTED IMAGE FILES MAY BE DELETED FROM THE PACS PERMANENTLY. CHANGE HEALTHCARE WILL WORK WITH AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO PREVENT THE RECURRENCE OF THE PROBLEM.

    Description of Event or Problem · 1

    FOLLOWING AN UPGRADE TO CHRS 14.0 A CUSTOMER SITE, THE CUSTOMER REPORTED ISSUES ON (B)(6) 2020 WHERE SOME NEWLY IMPORTED ULTRASOUND IMAGES WEREN'T IN ORDER AND SOME OF THEM WERE CUT OFF AND BLACK. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960586 CHANGE HEALTHCARE RADIOLOGY SOLUTIONS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ CHANGE HEALTHCARE CANADA COMPANY 14.0 17540262030020

    Patients

    Seq Age Sex Outcome Treatment
    1