Welch Allyn Vital Signs 300 Series

Device Name:

Vital Signs 300 Series

Manufacturer:

Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for patient monitoring

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Obsolete

Device Manual:

Click here to download the Device Manual

Description:

The Welch Allyn Vital Signs 300 Series is a vital signs monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for bedside patient monitoring. This device is now obsolete.

Assessment:

The technology used in the Welch Allyn Vital Signs 300 Series, to measure blood pressure, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has failed a clinical validation.
BP	BIHS (UK and IRL)	NOT recommended for pregnancy	Published evidence

Validation Publications:

Nzelu D, Yeung F, Couderq D, Shennan A, Kametas NA. An inaccurate automated device negatively impacts the diagnosis and treatment of gestational hypertension. Pregnancy Hypertens. 2017 Oct;10:28-33. Epub: 2017 May 3. doi: 10.1016/j.preghy.2017.05.001. PMID: 29143739.

ESH-IP:2010 - Fail Pregnancy (n=33)

Relevant Publications:

Schoot TS, Weenk M, van de Belt TH, Engelen LJLPG, van Goor H, Bredie SJH. A New Cuffless Device for Measuring Blood Pressure: A Real-Life Validation Study. J Med Internet Res. 2016 May;18(5):e85. Epub: 2016 May 05. doi: 10.2196/jmir.5414. PMID: 27150527. Available from: PMC4873623.

The reference device used was the Welch Allyn Vital Signs 300 Series. However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.