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

Model Number	VELA
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - the suspect device was not returned for evaluation.The unit was not returned; therefore a definitive root cause could not be determined.However, the customer attempted to calibrate the transducers and stated that the exp flow transducer was failing and that he would like to order a new main board.The part number was provided.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 is having a transducer fault during user verification tests (uvt).Furthermore, there was no patient associated with the reported event.

• 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18977648
• Report Number: 2021710-2024-18920
• Device Sequence Number: 6035942
• Product Code: CBK
• UDI-Device Identifier: 10846446001358
• UDI-Public: (01)10846446001358
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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: VELA
• Device Catalogue Number: 16600
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/26/2024
• 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