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

Model Number	AVEA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.The customer reported that the device passed the extended self test and oxygen sensor calibration.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported circuit occlusion, circuit disconnect, high fraction of inspired oxygen and fraction of inspired oxygen is out of tolerance on the avea ventilator.The customer reported there was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Device evaluation: result of investigation: the vyaire failure analysis lab (fa lab) was unable to duplicate or confirm the reported problem.The issue was resolved by shipping the customer a replacement product.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618
• MDR Report Key: 12018371
• Report Number: 2021710-2021-13999
• Device Sequence Number: 4269067
• Product Code: CBK
• UDI-Device Identifier: 10846446000016
• UDI-Public: (01)10846446000016(11)20100921
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: R17310-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown