MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	AVEA
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Vyaire field service representative (fsr) went onsite and evaluated the ventilator.Fsr noticed that while running operational verification procedure (ovp), vte was out of specification.Fsr calibrated all transducers and still out if specification and ran exhalation characterization and it failed 3 times.Fsr replaced exhalation valve and vte was still out of specification.Fsr detected that the flow sensor was loose, replaced exhalation flow sensor, bulkhead connector assembly, manifold exhalation, diaphragm, flow sensor and replaced purple rubber elbow with blue one.Vte was still out of spec.Replaced gas delivery engine (gde) and ran ovp.All tested ok.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
Event or Problem Description
The customer reported the tidal volume of the avea ventilator is low.Patient involvement is unknown at this time.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9946289
• Report Number: 2021710-2020-11771
• Device Sequence Number: 2628882
• Product Code: CBK
• UDI-Device Identifier: 10846446000351
• UDI-Public: (01)10846446000351(11)20091201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVEA
• Device Catalogue Number: AVEA COMP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1