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

Model Number	17310-00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
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.Est (extended systems test) passed and the unit was autocycling and peep was out of specification.Pm (preventive maintenance) was performed using a kit from oem (original equipment manufacturer) specialty products.The fsr replaced the poppet exhalation valve with the one supplied from vyaire and this corrected the peep issue.Ovp (operational verification procedure) was done and internal battery run test failed (unit only ran for 6 minutes).The charging circuit was reset and battery replacement was indicated prior to placing the unit back in service.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 low peak expiratory end pressure occurred on the avea ventilator.The customer reported there was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
H11:correction d4:corrected model# and catalog #.Section d4 was updated to indicate correct model # and catalog #.
Additional Manufacturer Narrative
Section d4 was updated to indicate correct udi.

• 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: 17962338
• Report Number: 2021710-2023-18266
• Device Sequence Number: 20750579
• Product Code: CBK
• UDI-Device Identifier: 10846446000047
• UDI-Public: (01)10846446000047(11)20160330
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup,Followup
• Report Date (Section B): 10/18/2023

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: 17310-00
• Device Catalogue Number: 17310-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: Not provided; 08/05/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 08/02/2024; 08/05/2024
• 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