BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESUITE ED PULSECHECK VERSION 3.8

    MDR report key: 1083548 · Received July 25, 2008

    Report

    Report Number
    3006076247-2008-00001
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    April 26, 2008
    Report Date
    July 25, 2008
    Manufacturer
    PICIS, INC.
    Product Code
    NSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL FACILITY REPORTED ON JUNE 27, 2008, THAT A PT SUFFERING FROM DEMENTIA ARRIVED IN THE EMERGENCY DEPARTMENT APPROX THREE MONTHS PRIOR. THE PT HAD A MEDICATION ORDER PLACED BY A PHYSICIAN ON A CUSTOM ORDER ENTRY SCREEN AND RECEIVED A MEDICATION TO WHICH HE WAS ALLERGIC RESULTING IN AN ALLERGIC REACTION REQUIRING STANDARD TREATMENT. HE FULLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL WITHIN 48 HRS. THE CUSTOM ORDER ENTRY SCREEN DISPLAYED A PLACEHOLDER INDICATING NO ALLERGY INFO HAD BEEN RECORDED ON THIS VISIT. THERE WAS A HISTORICAL ALLERGY ENTRY THAT DID NOT DISPLAY ON THE CUSTOM ORDER ENTRY SCREEN, BUT DID DISPLAY ON ALL OTHER SCREENS. THE CUSTOMER ORDER ENTRY SCREEN IS INTENDED FOR ANCILLARY ORDERS (E.G., LABS, X-RAYS, NURSING ORDERS) AND IS NOT INTENDED FOR USE WITH MEDICATION ORDERS. THE CUSTOM ORDER ENTRY SCREEN REQUIRES A MEDICAL RECORD NUMBER (OBTAINED VIA REGISTRATION) TO DISPLAY ALLERGIES FROM PREVIOUS VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESUITE ED PULSECHECK VERSION 3.8 SW, TRANSMISSION & STORAGE, PATIENT DATA NSX PICIS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R