MAUDE Adverse Event Report: VYAIRE MEDICAL INC. 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	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that ventilator inoperable alarm occurred on the avea ventilator.At this time, there is no information regarding patient involvement associated with the reported event.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Results of investigation:vyaire medical received the device for evaluation.Technician visually inspected on uut (unit under test) assembly, the gas delivery engine assembly was received with no esd bag protection.The uut was installed in a known good avea test stand station.Powered in user mode where the unit showed ventilator inoperable fault alarms upon start-up.Installed a known good tca assembly and the uut was found to be functioning as intended, no vent inop alarms.Removed and installed tca assembly into avea tca test fixture.Powered into user mode where the unit showed ventilator inoperable fault alarms upon start-up.The reported complaint was able to be confirmed and duplicated.This is isolated to tca assembly.

• 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: 15421192
• Report Number: 2021710-2022-16624
• Device Sequence Number: 14149643
• Product Code: CBK
• UDI-Device Identifier: 10846446000368
• UDI-Public: (01)10846446000368(11)20041231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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
• Device Catalogue Number: 17312-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2004
• 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