MAUDE Adverse Event Report: VYAIRE MEDICAL 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	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).Vyaire medical was able to confirm the issue, and a vyaire field service representative (fsr) evaluated the device on-site and replaced the o2 (oxygen) cell, resolving the issue.Blending accuracy was checked, and everything was within specifications.Ran a performance check; the unit passed all tests and operates in accordance with oem (original equipment manufacturer) specifications.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 to vyaire medical that the avea ventilator was having a high fraction of inspired oxygen (fio2) alarm.Furthermore, there was no patient associated with the reported event.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 14808265
• Report Number: 2021710-2022-16328
• Device Sequence Number: 11915460
• Product Code: CBK
• UDI-Device Identifier: 10846446000672
• UDI-Public: (01)10846446000672(11)20050513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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: 17311-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2005
• 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