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

Model Number	AVEA
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H10: a vyaire field service representative(fsr) evaluated the device onsite and the unit was miising an 02 cell.The 02 cell was installed,nasal cannula calibtared and ran settings from the reported issue.The ncpap (nasal continuous positive airway pressure) flow was reading 18.1 l/min.With settings of 40 rate,16 insp pres,.5 insp time, 6 ncpap, and 40% fio2.The fsr took the same test equioment and tested on another avea with the same settings.The other unit had a similar reading of 17.5 l/min.There could be a possible issue with the customer circuit or nasal cannula.The customer did not have the patient circuit that the issue was reported on.Ovp (operational verification procedure)and est (extended systems test) was run and the unit passed all tests and runs according to 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
It was reported to vyaire medical that drop in pressure on ncpap (nasal continuous positive airway pressure) mode occurred on the avea ventilator.They have the value set at 6 cmh20 but it drops to 2 cmh20.The customer reported there was no patient involvement associated with the reported event.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18369368
• Report Number: 2021710-2023-18546
• Device Sequence Number: 12657389
• Product Code: CBK
• UDI-Device Identifier: 10846446000368
• UDI-Public: (01)10846446000368
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/20/2023

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: 17312-00
• 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: 11/29/2023
• Initial Report FDA Received Date: 12/20/2023
• 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