BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAMIC DOCUMENTATION

    MDR report key: 4269368 · Received October 17, 2014

    Report

    Report Number
    1931259-2014-00011
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 16, 2014
    Manufacturer
    CERNER CORPORATION
    Product Code
    OUG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER DISTRIBUTION A PRIORITY REVIEW FLASH NOTIFICATION ON OCTOBER 15, 2014 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, AN ALTERNATIVE TO PREVENT THE ISSUE FROM OCCURRING, AND NOTIFICATION THAT A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE SOFTWARE MODIFICATION IS AVAILABLE.

    Description of Event or Problem · 1

    DYNAMIC DOCUMENTATION PULLS DATA FROM THE PATIENT CHART AND ALLOWS END USERS TO ENTER FREE TEXT ALONGSIDE CHART DATA TO CREATE DOCUMENTS SUCH AS PROGRESS NOTES. THE ISSUE OCCURS WHEN A SINGLE-COLUMN TABLE IS ADDED IN A NOTE, EITHER BY A SMART TEMPLATE OR BY COPYING AND PASTING TEXT. WHEN THIS OCCURS THE CONTENT BELOW THE FIRST ROW OF THE TABLE IS LOST WHEN THE NOTE IS SAVED OR SIGNED. PATIENT CARE COULD BE IMPACTED IF THE INFORMATION THAT IS LOST IS NECESSARY FOR TREATMENT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661283 DYNAMIC DOCUMENTATION SOFTWARE OUG CERNER CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1