FDA recall Z-2805-2020

Precision Valve & Automation,Inc · Class II · device

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.

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.

Key facts

Status
Ongoing
Initiation date
2020-06-26
Report date
2020-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cohoes, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2805-2020