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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.