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

Model Number	VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY ACCOUNT NAME
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 requested an fse (field service engineer) repair.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 yet.
Event or Problem Description
It was reported to vyaire medical that the vela ventilator had a circuit disconnect alarm back on (b)(6) while on a patient use.Furthermore, there was no patient harm reported associated with this event.Customer confirmed that the unit was replaced by a different ventilator.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 and h11.Results of investigation: vyaire medical was able to verify the reported issue.The suspect device was not returned for investigation.However, as per work order performed under wo-00179310, it has been noticed that customer is using ex flow sensor for an avea unit with the longer tubes.The flow sensor receptacle is also incorrect.The flow sensor receptacle installed does not go with the unit.The diaphragm had the nipple facing inwards.Field service engineer corrected it all.Removed main board and installed new flow sensor receptacle for the vela unit.Installed new flow sensor.Reconnected main board and reassembled unit.Ran verification.All tests passed required criteria.Unit meets factory specifications.

• 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: 18026343
• Report Number: 2021710-2023-18323
• Device Sequence Number: 7684561
• Product Code: CBK
• UDI-Device Identifier: 10846446001501
• UDI-Public: (01)10846446001501
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/27/2023

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 ACCOUNT NAME
• Device Catalogue Number: 16531-00
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 08/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown