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

Model Number	16532-00
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the ventilator went inoperable while on a patient.There was no patient harm reported.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.No patient harm was reported.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.
Additional Manufacturer Narrative
D9: device was not returned for evaluation, however it was evaluated and repaired onsite.H3: findings/root cause: the customer's reported issue was able to be confirmed.Unit was auto-cycling intermittently at startup.Wiring and cables were reseated to the mainboard, blender and power supply.There was a loose connection of flow sensor to the mainboard, the connection was secured.Drying tube from the exhalation valve to solenoid appeared damaged at connector on exhalation valve receptacle size.Removed tube and confirmed fraying at the end of the tubing.The tube was wrapped and reinstalled.Auto-cycling was no longer present after repair.Allowed vent to ventilate at 100 fio2 for warm-up.All tests passed required criteria.Unit meets factory specs.

• Brand Name: VELA
• 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: 19510217
• Report Number: 3013421741-2024-00170
• Device Sequence Number: 3455643
• Product Code: CBK
• UDI-Device Identifier: 10190752153325
• UDI-Public: (01)10190752153325(11)20070425
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 16532-00
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2007
• 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