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

Model Number	AVEA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire complaint number (b)(4).The device was not returned to vyaire; however, vyaire technical support team arrived at site and checked unit operation.The reported error could not be duplicated.Unit was working to manufacturing specifications.
Event or Problem Description
A customer contacted vyaire medical to report that they encountered a high fio2 and low fio2 alarms continuously on the avea ventlator.At this time, it is unknown if there was any patient involvement or harm.

• Brand Name: AVEA CMPRH,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: 11873803
• Report Number: 2021710-2021-13956
• Device Sequence Number: 3215311
• Product Code: CBK
• UDI-Device Identifier: 10846446000023
• UDI-Public: (01)10846446000023(11)20051215
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: 17210-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1