BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE DOCUMENTATION

    MDR report key: 1723929 · Received June 9, 2010

    Report

    Report Number
    1931259-2010-00005
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 9, 2010
    Manufacturer
    CERNER CORPORATION
    Product Code
    NSX
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION ON (B)(4), 2010 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND AN INTERIM WORKFLOW ADJUSTMENT TO PREVENT THE MALFUNCTION. A SOFTWARE MODIFICATION IS BEING DEVELOPED AND TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE SOFTWARE CORRECTION IS AVAILABLE.

    Description of Event or Problem · 1

    PT CARE COULD BE ADVERSELY AFFECTED, AS CLINICAL DECISIONS COULD BE BASED ON INCOMPLETE INFORMATION, RESULTING IN THE POTENTIAL FOR INAPPROPRIATE CARE TO BE GIVEN. CERNER HAS NOT RECEIVED COMMUNICATION OF ANY ADVERSE PT EVENTS AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE DOCUMENTATION SOFTWARE NSX CERNER CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1