Vyaire file identification: (b)(4).At this time, the defective device has not been returned for evaluation.Therefore, the root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
|
The customer reported multiple issues on 002620-a humidifier kit 500ml 12/cs.When the flow is set to >4lpm, the humidifier squeals due to backpressure.The front part where you twist off the adapter to connect to the patient tubing does not create an orifice for flow to pass through, or is too small, resulting in increased back pressure from tubing obstruction and creating a fountain of water, dousing contents to the staff, patients, and room.There was no clear information on patient involvement.
|