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

Model Number	16600
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that low volume when set at 500, but unit is giving 227.Unknown patient involvement was reported.
Additional Manufacturer Narrative
Vyaire medical file indentification: (b)(6).D4: device was manufactured in 2007 and was not subject to udi requirements.H3: 81 other: currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.No patient harm was reported.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VELA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 north 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 ; 2402760001
• MDR Report Key: 20352833
• Report Number: 3013421741-2024-00458
• Device Sequence Number: 7983228
• Product Code: CBK
• UDI-Device Identifier: 10190752154230
• UDI-Public: (01)10190752154230
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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 Model Number: 16600
• Device Catalogue Number: 16600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2007
• 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
• Patient Sex: Unknown