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

Model Number	VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY
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).H3: 81 other - the suspect device has not been returned for evaluation.Therefore, root cause has not been determined.Additionally, the customer indicated that they have retired the ventilator.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text: device not returned.
Event or Problem Description
It was reported to vyaire medical that the vela ventilator had problems with vti (tidal volume of inspiration) and vte (tidal volume of expiration) that were inaccurate.Vti reads 439ml and the vte reads 397ml.Furthermore, there is no information regarding patient associated with the reported event.

• Brand Name: VELA 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 17909015
• Report Number: 2021710-2023-18264
• Device Sequence Number: 12652424
• Product Code: CBK
• UDI-Device Identifier: 10846446001501
• UDI-Public: (01)10846446001501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2023

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: VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY
• Device Catalogue Number: 16531-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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