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

Model Number	AVEA STANDARD
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The device was not returned for further evaluation; therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.However, the customer was provided with calibration codes.
Event or Problem Description
The customer reported to vyaire medical that the avea ventilator was experiencing a positive end-expiratory pressure (peep) instability and requested a peep calibration code.The event happened during set up prior patient use.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 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 ; 7149227837
• MDR Report Key: 14428918
• Report Number: 2021710-2022-16005
• Device Sequence Number: 12163577
• Product Code: CBK
• UDI-Device Identifier: 10846446000023
• UDI-Public: (01)10846446000023(11)20080620
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

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 STANDARD
• Device Catalogue Number: R17210-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2008
• 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