MAUDE Adverse Event Report: VYAIRE MEDICAL 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	02/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that immediately when the vela ventilator was powered on, low ve (minute ventilation), high pip (peak inspiratory pressure), and high rate alarms were triggered during patient use.Furthermore, the patient was transferred to another device and there was no patient harm associated with the event.
Additional Manufacturer Narrative
The customer reported that they will not return the defective part/unit for evaluation.Therefore, no root cause could be determined.However, the customer placed an order and part will be shipped.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.Device will not be returned.

• Brand Name: VELA VENTILATOR
• 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: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 16556280
• Report Number: 2021710-2023-17418
• Device Sequence Number: 20081451
• Product Code: CBK
• UDI-Device Identifier: 10846446001501
• UDI-Public: (01)10846446001501(11)20181127
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown