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

Catalog Number	16532-00
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical requesting a field service engineer (fse) to evaluate the vela ventilator due to the ventilator reading 0ml.
Additional Manufacturer Narrative
He: 81-other-the customer has requested vyaire field service to come onsite and evaluate the suspect device.As of the submission of this report the onsite visit has not taken place.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Vyaire medical's field service team went onsite to evaluate the suspect device.The main board was replace due to transducer fault and vti/vte of 450/0 on startup.The main board was replaced successfully and all tests passed required criteria.The unit meets factory specifications.
Additional Manufacturer Narrative
Results of investigation: vyaire medical received the device for evaluation.Technician visually inspected vela printed circuit board assy, found no signs of misuse or damage.Installed pcba on to a known good vela test fixture and connected unit to ac power.Powered unit into user mode, where the unit would autocycle/ ventilate abnormally and alarm the following: alarm circuit disconnect, high pip, low ve and xdcr fault.Confirmed vte to monitor value to be at 0ml.Cycled the power into service mode and reviewed of the events log showed alarm circuit disconnect, high pip, low ve, xdcr fault and xdcr fault occurred recorded on 11march2024.Alarm circuit disconnect, high pip, xdcr fault and xdcr fault was recorded on the most recent events.The reported complaint was confirmed through the events log and duplicated during functional check.Transducer pt802 (exhalation flow transducer) has failed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VELA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL,; 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 ; 2402760001
• MDR Report Key: 18890672
• Report Number: 2021710-2024-18881
• Device Sequence Number: 18040027
• Product Code: CBK
• UDI-Device Identifier: 10846446001419
• UDI-Public: (01)10846446001419(11)20100622
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2024

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: 16532-00
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: Not provided; 09/04/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 08/06/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2010
• 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