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

Catalog Number	16531-00
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file indentification: (b)(4).H3: 81 other ¿ currently, the suspect device has not been returned for evaluation.The customer has requested an onsite evaluation.The result of the evaluation is not currently available.A root cause has not been determined.Patient was involved; currently, injury or harm is has not been determined.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 the customer is unable to set volume on the vela ventilator unit.The ventilator was on a patient when the reported issue occurred.Patient injury or harm is unknown at this time.
Additional Manufacturer Narrative
Results of investigation: vyaire medical field service technician went onsite to evaluate the device.Used personal test equipment and volumes were at 500ml.Issue with customer flow sensor and body valve.Flow sensor was reading 100ml less than test flow sensor.Body valve was cracked and patient circuit was loose on it when connect/ test other flow sensors that customer had, found a few that were under slightly under 450ml.Suggested customer to get some replacements.Customer also report low fraction of inspired o2xygen.Ran blending accuracy test and fraction of inspired o2xygen at 30%, 60%, 90%, and 100% were within specifications.Ran owner verification process, unit passed all test and runs according to manufacturer specifications.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: 19120549
• Report Number: 2021710-2024-19023
• Device Sequence Number: 15543483
• Product Code: CBK
• UDI-Device Identifier: 10846446001501
• UDI-Public: (01)10846446001501(11)20110112
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 16531-00
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2011
• 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