BEUDAMED
    FDA Adverse Event Summary report: N

    MILLENIUM

    MDR report key: 1288623 · Received December 18, 2008

    Report

    Report Number
    1288623
    Date Received
    December 18, 2008
    Date of Event
    December 11, 2008
    Report Date
    December 17, 2008
    Manufacturer
    CERNER CORPORATION
    Product Code
    NSX
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    NURSES ARE CURRENTLY MANUALLY ENTERING VITAL SIGNS DATA INTO THE ELECTRONIC MEDICAL RECORD (EMR). NURSES HAVE NOTICED THAT THE MEAN PRESSURE VALUE THAT IS CALCULATED BY THE EMR IS SOMETIMES DIFFERENT FROM THE MEAN VALUE DISPLAYED ON THE PATIENT MONITOR. A FEW SAMPLE VALUES WERE OBTAINED: (SYSTOLIC/DIASTOLIC MEAN) 129/65 81 EMR MEAN 86; 146/78 95 EMR 101; 134/54 81 EMR 84; 150/98 116 EMR 115. WE WERE UNABLE TO VERIFY IF THIS OCCURS WITH A DIFFERENT PATIENT MONITORING VENDOR (SUCH AS IN THE ER) BECAUSE IN THAT CASE THE EMR DOES NOT DISPLAY THE MEAN VALUE. NURSES REPORTING THIS PROBLEM SAY THAT THEY HAVE SEEN MUCH LARGER VARIATIONS BUT I DO NOT HAVE SPECIFIC NUMBERS TO REPORT YET.====================== MANUFACTURER RESPONSE FOR PATIENT MONITOR, (BRAND NOT PROVIDED)======================PER CLINICAL SUPPORT WITH GE, THE MEAN PRESSURE IS MEASURED IN THE OSCILLOMETRIC METHOD AND IS THE MOST ACCURATE PRESSURE VALUE SINCE THE SYSTOLIC AND DIASTOLIC ARE THEN CALCULATED FROM THE MEAN. MOST EMR'S TAKE THE SYSTOLIC AND DIASTOLIC NUMBERS AND THEN CALCULATE THE MEAN USING A FORMULA INTENDED FOR AUSCULTATORY READINGS. THEREFORE THERE WILL BE VARIATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENIUM ELECTRONIC MEDICAL RECORD NSX CERNER CORPORATION MILLENIUM NA
    2 * MONITOR, PHYSIOLOGICAL MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DASH AND SOLAR MONITOR (AMONG OTHERS) *

    Patients

    Seq Age Sex Outcome Treatment
    1 *