MAUDE Adverse Event Report: VYAIRE MEDICAL INC VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY; VELA VENTILATOR

Catalog Number	16532-00
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
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.However, it was advised to calibrate all transducers.Transducers were calibrated and turbine pressure failed.It was informed that the mainboard needed to be replaced.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : not returned to manufacturer.
Event or Problem Description
It was reported to vyaire medical that during preventative maintenance the vela vent has xdcr motor fault, low pip and low vte.No patient involvement was reported.

• Brand Name: VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY
• Common Device Name: VELA VENTILATOR
• 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: 19186000
• Report Number: 3013421741-2024-00095
• Device Sequence Number: 15261859
• Product Code: CBK
• UDI-Device Identifier: 10846446001419
• UDI-Public: (01)10846446001419(11)20151216
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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 Catalogue Number: 16532-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2015
• 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