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

Model Number	VELA VENTILATOR
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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 to vyaire medical that the vela ventilator is having issue with power and the screen was flickering.It was determined that the lcd cable needed to be replaced but after replacement, the main display remains black.When unit is turned on, no alarms are noted but the fan comes on.And on the main board, only one led is lit, rather than 4.At this time there was no information of patient involvement associated from this event.

• 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: 14528868
• Report Number: 2021710-2022-16095
• Device Sequence Number: 5837110
• Product Code: CBK
• UDI-Device Identifier: 10846446001501
• UDI-Public: (01)10846446001501(11)20080321
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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 VENTILATOR
• Device Catalogue Number: 16531-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2008
• 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