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510(k) Data Aggregation
K Number
K124038Device Name
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
Manufacturer
BEDSIDE CLINICAL SYSTEMS INC
Date Cleared
2013-06-21
(175 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
BEDSIDE CLINICAL SYSTEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bedside Paediatric Early Warning System (BedsidePEWS™) is an electronic documentation tool that is designed to be used in conjunction with multi-parameter patient monitoring. It is indicated for use by healthcare professionals with paediatric patients between the ages of term newborn (>37 weeks gestational age) and 18 years, who are hospitalized with any medical or surgical condition.
BedsidePEWS™ allows input by the healthcare professional of commonly recorded vital sign data and provides clinician with a patient status index (the "BedsidePEWS™ score") based on a weighted average of seven vital signs when entered by the clinician, namely Heart Rate, Respiratory Rate, Blood Pressure, Oxygen Saturation, Oxygen Therapy, Respiratory Effort, and Capillary Refill. The "BedsidePEWS™ score" is a single measure of a patient's condition and indicates the variation in the patient's vital signs with respect to normality. BedsidePEWS™ is an adjunct to and is not intended to replace vital signs monitoring.
BedsidePEWS™ is intended for use in wards and the emergency rooms in hospitals that provide care for children between the ages of term newborn (>37 weeks gestational age) and 18 years. It is not intended for use in the Neonatal Intensive Care Unit.
Device Description
The product is a web-based clinical decision-support tool that can also be run as a standalone application for use on computers running Microsoft Software Operating features with a local network connection, which access medical data. It is also interfaces to other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), and Practice Management Software.
The software device consists of a SQL compatible database that provides access to the patient specific information and allows clinicians to input patient data (i.e. heart rate, respiratory rate, blood pressure, oxygen saturation, oxygen therapy, respiratory effort, and capillary refill time) to deliver actionable information, such as recommended follow-up and/or guideline for further and subsequent clinical assessments, and analytics of patients through real-time vital signs monitoring algorithm.
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