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

Model Number	AVEA
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).The customer reported that they will not return the defective part/unit for evaluation.Therefore, no root cause could be determined.However, the customer mentioned that the reported issue has been resolved.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device will not be returned.
Event or Problem Description
It was reported to vyaire medical that ventilator is making hissing sound and battery discharge from the avea ventilator during preventive maintenance.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: 18548946
• Report Number: 2021710-2024-18683
• Device Sequence Number: 9080655
• Product Code: CBK
• UDI-Device Identifier: 10846446066074
• UDI-Public: (01)10846446066074
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/20/2024

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: 32029-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 01/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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