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.
Enforcement
- Recall Number
- Z-2805-2020
- Event ID
- 86082
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Precision Valve & Automation,Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- August 26, 2020
- Initiation Date
- June 26, 2020
- Classification Date
- August 14, 2020
- Address
- 1 Mustang Dr, N/A, Cohoes, NY, 12047-4856, United States
Description
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.
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.
Lot #: EV123732 Serial #s: L1002, L1005, L1006
Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
3 units