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

Model Number	VELA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire medical that vent inoperable, motor fault, transducer fault, low ve (low minute ventilation), and low pip (peak inspiratory pressure) alarms occurred on vela ventilator.The issue occurred during patient-use and the device was replaced with another ventilator.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
The suspect device/component will not be returned for evaluation.Therefore, no root cause could be determined.However, the event log shows that an xdcr fault occurred, that xdcr tests were performed, and that turb diff: 1021 failed.Performed xdcr cals, exhl diff press transducer failed at 0 cmh2o.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56.If additional information becomes available.

• 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: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13506985
• Report Number: 2021710-2021-15422
• Device Sequence Number: 20112551
• Product Code: CBK
• UDI-Device Identifier: 10846446001600
• UDI-Public: (01)10846446001600(11)20130315
• 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): 01/13/2022

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
• Device Catalogue Number: 16530-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2013
• 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