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	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.
Event or Problem Description
The customer reported that the avea unit display is not working.There is no patient involvement in this reported event.
Additional Manufacturer Narrative
Results of investigation: our vyaire failure analysis team (fsr) could not duplicate or confirm the reported customer issue.It was suggested the intermittent blank display could be a possible failure of the o2 blender.The o2 blender was replaced and disposed of as a precautionary measure.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10007732
• Report Number: 2021710-2020-11831
• Device Sequence Number: 11477469
• Product Code: CBK
• UDI-Device Identifier: 10846446000351
• UDI-Public: (01)10846446000351(11)20050801
• 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): 05/24/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1