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	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56.If additional information becomes available.
Event or Problem Description
The customer reported circuit disconnect and low peak inspiratory pressure during use on a patient on the vela ventilator.At this time, there is no information regarding patient harm associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire received the device for evaluation.Technician visually inspected the assembly, there were no visible defects, damage or contamination.Component was installed in known good vela host base unit.Ventilator was powered in ventilate mode where the unit showed the following alarms upon start-up: ventilator inoperable, transducer faults.Device was powered in service mode.The event log shows multiples transducer faults for exhalation pressure transducer ( pt801 ).The reported complaint was confirmed and duplicated.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
• MDR Report Key: 12306575
• Report Number: 2021710-2021-14246
• Device Sequence Number: 17061712
• Product Code: CBK
• UDI-Device Identifier: 10846446001600
• UDI-Public: (01)10846446001600(11)20110919
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• 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): 07/14/2021

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: 16530-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2011
• 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