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

Model Number	VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, customer supplied information regarding ventilator for ordering replacement of main board.Vyaire is placing a work order on hold until part arrives.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 vela ventilator has transducer fault occurred (1,0,1311) ex flow transducer.Furthermore there waas no patient associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was able to verify the customer complaint.The suspect device was returned for investigation.Vyaire received vela main pcb p/n 52850 s/n bd280201167s.A visual inspection of pcb was performed and found no indications of damage, misuse, or contamination.The uut (unit under test) was installed into a known good vela test unit and powered into service mode.Pcb was found to be running software version 03.02.00.A review of events log found several xdcr (transducer) faults.Then proceeded to perform transducer calibrations as described in vela service manual 33373-001 chapter 6.The reported complaint was duplicated.Transducer p/n 68354 was found to be failing at zero calibration.This is a known issue that has been addressed with capa-000000281, scar ps-16-23, eco 102677.

• 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: 18865866
• Report Number: 2021710-2024-18862
• Device Sequence Number: 16978691
• Product Code: CBK
• UDI-Device Identifier: 10846446001419
• UDI-Public: (01)10846446001419
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/08/2024

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 CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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