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

Model Number	16532-00
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).Powered on unit and confirmed vent inop alarm.Unit also alarming motor fault and xdcr fault.Replaced turbine and motor fault alarm disappeared.Replaced main board resolved issue.Put old turbine back and got motor fault again.Replaced turbine and resolved issue.Ran uvt and ovp, unit passed all test and runs according to oem specs.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 the ventilator was turned on and immediately gave circuit occlusion and vent inop alarm.He swapped the circuit and that did not resolve the issue.No patient involvement.
Additional Manufacturer Narrative
H3: powered on unit and confirmed vent inop alarm.Unit also alarming motor fault and and xdcr fault.Replaced turbine and motor fault alarm disappeared.Replaced main board resolved issue.Put old turbine back and got motor fault again.Replaced turbine and resolved issue.Ran uvt and ovp, unit passed all test and runs according to oem specs.
Event or Problem Description
Additional information received indicates that a vyaire medical fse was able to go to customer site and resolve the issue.

• Brand Name: VELA
• 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: 19537559
• Report Number: 3013421741-2024-00184
• Device Sequence Number: 17685080
• Product Code: CBK
• UDI-Device Identifier: 10190752153325
• UDI-Public: (01)10190752153325(11)20150319
• Combination Product (Y/N): N
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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 Model Number: 16532-00
• Device Catalogue Number: 16532-00
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2015
• 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