BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 6136666 · Received November 30, 2016

    Report

    Report Number
    8022257-2016-00003
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K140909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON HAS IDENTIFIED A SOFTWARE DEFECT THAT IS ENCOUNTERED WHEN USERS LOGIN TO THE PACS FROM AN EMR, OR USING LEGACY WEB URL. AS A RESULT OF THE SOFTWARE DEFECT, THE USER MAY EXPERIENCE MISSING IMAGES IN A NEWLY IMPORTED STUDY, AND/OR STUDY IMPORTS THAT REMAIN IN AN "IN-PROGRESS" STATUS. MCKESSON WILL WORK WITH AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO PREVENT THE RECURRENCE OF THE PROBLEM.

    Description of Event or Problem · 1

    THE REPORTING FACILITY HAD REPORTED A ONE HOUR DELAY IN CARE FOR A (B)(6) YEAR OLD STROKE PATIENT DUE TO A FAILURE TO IMPORT ALL STUDY IMAGES INTO THE PACS SYSTEM. THE REPORTING FACILITY PERFORMED ALTERNATIVE MEASURES TO VIEW THE STUDY IMAGES TO TREAT THE STROKE PATIENT. NO HARM TO THE PATIENT WAS REPORTED AS A RESULT OF THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786582 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMMUNICATION SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.2

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR