FDA adds portable resuscitator to ventilator EUA list
The Food and Drug Administration yesterday added the AustinP51 emergency-use system to its list of ventilator authorized for emergency use in health care settings to treat adults during the COVID-19 pandemic.
The device is a portable emergency use resuscitator designed to provide either continuous or intermittent ventilatory support for patients requiring mechanical ventilation through volume control.
The agency said the AustinP51 should only be used by professionals who are qualified and trained in the use of general ventilation equipment, or who are specifically trained on the AustinP51 system.
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