BEUDAMED
    FDA Adverse Event Summary report: N

    ED PULSECHECK

    MDR report key: 5207139 · Received November 6, 2015

    Report

    Report Number
    3005244943-2015-00004
    Date Received
    November 6, 2015
    Report Date
    October 22, 2015
    Manufacturer
    PICIS CLINICAL SOLUTIONS, INC.
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PICIS CLINICAL SOLUTIONS RECEIVED AN ENHANCEMENT REQUEST ON (B)(6)-2015: "PLEASE, PLEASE, PLEASE, PLEASE!!! WE'VE RECENTLY HAD TWO NEAR MISSES WITH PATIENT WEIGHTS. THE MOST RECENT HAD TO DO WITH CHARTING POUNDS IN THE KG FIELD. WE REALLY NEED THE LBS FIELD TO NOT BE AVAILABLE . " FURTHER INVESTIGATION DETERMINED THAT THERE WERE NO REPORTED PATIENT INCIDENTS RELATED TO THE ENHANCEMENT REQUEST. THE ED PULSECHECK PRODUCT CURRENTLY HAS TWO TEMPLATE FIELDS FOR THE DOCUMENTATION OF A PATIENT'S WEIGHT, A FIELD TO DOCUMENT IN POUNDS AND A FIELD TO DOCUMENT WEIGHT IN KILOGRAMS. THE CLINICIAN MUST DOCUMENT IN THE FIELD THAT CORRESPONDS TO THE UNITS IN WHICH THE WEIGHT WAS MEASURED. THE NEAR MISSES REPORTED WERE RELATED TO A CLINICIAN DOCUMENTING INACCURATE INFORMATION INTO A CLEARLY LABELED TEMPLATE FIELD WITHIN ED PULSECHECK. PICIS CLINICAL SOLUTIONS, INC. IS PLANNING TO RELEASE THE NEXT VERSION OF THE ED PULSECHECK PRODUCT. THIS VERSION OF ED PULSECHECK (V5.6) WILL INCLUDE AN ENHANCEMENT OPTION TO ONLY DISPLAY THE KG FIELD FOR WEIGHT DATA ENTRY. THIS ENHANCEMENT MAY MINIMIZE THE RISK OF A DATA ENTRY ERROR, ALTHOUGH THE ENHANCEMENT DOES NOT PREVENT THE RISK OF DATA ENTRY ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738279 ED PULSECHECK SOFTWARE, TRANSMISSION AND STORAGE NSX PICIS CLINICAL SOLUTIONS, INC. 5.5

    Patients

    Seq Age Sex Outcome Treatment
    1