medical Class II Updated 2020-08-26

Precision Valve & Automation,Inc recalls PVA, PREVENT is an FDA-authorized emergency ventilator desig

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: EV123732 Serial #s: L1002, L1005, L1006
View official government recall

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