Reported Aug 26, 2020 · Ongoing
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory…
Precision Valve & Automation,Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Precision Valve & Automation,Inc · 1 Mustang Dr · Cohoes, NY · 12047-4856
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: EV123732 Serial #s: L1002L1005L1006
- Amount recalled
- 3 units
Where it was sold
- Nationwide
- NY
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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