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.
Recall
- Recall Number
- Z-2805-2020
- Event Number
- 86082
- Firm
- Precision Valve & Automation, Inc
- FEI Number
- 3001151872
- Product Code
- BTL
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- June 26, 2020
- Address
- 1 Mustang Dr, Cohoes, NY, 12047-4856
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.
Customers will be e-mailed initial recall notice, followed by written letter. Customers will be directed to ship recalled PreVENT back to PVA as soon as possible. Recalled unit will be shipped back to PVA in the same packaging from replacement unit. Recalled units will be scrapped at PVA.
Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
3 units