MAUDE Adverse Event Report: VYAIRE MEDICAL VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the vela ventilator was failing the exhalation transducer calibration.It was stated that when trying to zero the exhalation pressure transducer, the ad reads 4000.There was no patient involved in this reported event.
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).The suspect device/part was not returned for evaluation.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

• Brand Name: VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY
• 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: 15916248
• Report Number: 2021710-2022-16991
• Device Sequence Number: 6723052
• Product Code: CBK
• UDI-Device Identifier: 10846446001501
• UDI-Public: (01)10846446001501(11)20140130
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2014
• 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