MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number	AVEA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A vyaire field service engineer (fse) went onsite and evaluated the ventilator.Troubleshooting indicated a faulty gas delivery engine (gde).As per fse, the unit needs new gde to be repaired and put back in service.The part will be sent to vyaire failure analysis laboratory for further investigation.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 that the avea ventilator is alarming o2 cell error.A message appears stating that o2 concentration is low.There was no patient involvement.
Additional Manufacturer Narrative
Corrected information: the part was not sent to vyaire failure analysis laboratory for further investigation, instead the gde (gas delivery engine) and uim (user interface module) were sent to the factory for replacement.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9998812
• Report Number: 2021710-2020-11865
• Device Sequence Number: 14541725
• Product Code: CBK
• UDI-Device Identifier: 10846446000351
• UDI-Public: (01)10846446000351(11)20051215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 17212-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1