Recall Z-2805-2020— Precision Valve & Automation,Inc
Class II · Ongoing
Class II FDA medical device recall by Precision Valve & Automation,Inc, initiated 2020-06-26. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Precision Valve & Automation,Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-06-26
- Firm location
- Cohoes, NY, United States
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.