Recall – Ventilator false alarm can affect inhale/exhale ratio

Company: Precision Valve & Automation, Inc.
Date of Enforcement Report: 8/26/2020
Class II

PRODUCT

PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

Recall Number: Z-2805-2020

REASON

While operating the machine in “Run” mode, an unexpected event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.

RECALLING FIRM/MANUFACTURER

Precision Valve & Automation, Inc. on 6/26/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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