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

Catalog Number	32029-001
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical investigation file # (b)(4).H3: 81 other ¿ currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.No patient involvement.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : the device has not been returned for evaluation.
Event or Problem Description
It was reported to vyaire medical, the avea ventilator is giving low o2 alarm.No patient involvement.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 & h11.Results of investigation: vyaire medical field service technician went onsite to evaluate the device.Technician installed pm kit 16138, internal battery pack, and oxygen sensor.Made necessary adjustments for proper operation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 north 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 ; 8478865998
• MDR Report Key: 19376920
• Report Number: 3013421741-2024-00124
• Device Sequence Number: 7529090
• Product Code: CBK
• UDI-Device Identifier: 10846446066074
• UDI-Public: (01)10846446066074(11)20201120
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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 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: 04/29/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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