MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA STD,N/CMP,ENG LNG,LO V,DISS,K; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	AVEA STANDARD
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, 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.
Event or Problem Description
A customer contacted vyaire medical to report that the avea unit had a high fio2 alarm.At this time, it is unknown if there was any patient involvement or harm.
Additional Manufacturer Narrative
Vyaire complaint number (b)(4).The sample was returned for evaluation.The vyaire medical failure analysis technician was able to confirm and duplicated the reported issue.Cause was identified as blender assembly part.

• Brand Name: AVEA STD,N/CMP,ENG LNG,LO V,DISS,K
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11806816
• Report Number: 2021710-2021-13894
• Device Sequence Number: 3909335
• Product Code: CBK
• UDI-Device Identifier: 10846446000672
• UDI-Public: (01)10846446000672(11)2050328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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 STANDARD
• Device Catalogue Number: 17311-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1