FDA-Device2020-08-26Class II
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.
Precision Valve & Automation,Inc
Hazard
While operating the machine in "Run" mode an unexcepted 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.
Sold states
Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
Affected count
3 units
Manufactured in
1 Mustang Dr, N/A, Cohoes, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2805-2020Don't want to check this manually?
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