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

Model Number	301.100.000
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use, the device experienced a technical failure 379, "no o2 dosing possible".Complainant indicated that there was no patient involvement in the reported issue.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.G4.Pma/510k#: the device is a similar device marketed in foreign countries and is not marketed under the 510k.
Additional Manufacturer Narrative
The device log files were provided to technical support for evaluation.A review of the device log files confirmed the reported alarm and indicated a leak in the o2 proportional valve.The o2 valve was replaced, which resolved the reported malfunction and the device was confirmed to be operating as intended after repair.

• Brand Name: BELLAVISTA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd; mettawa IL 60045
• Manufacturer Contact: mindy faber ; plo 1, jalan firma 1, kawasan; perindustrian tebrau 1; johor bahru ; MY
• MDR Report Key: 24691379
• Report Number: 3013421741-2026-00121
• Device Sequence Number: 9855271
• Product Code: CBK
• UDI-Device Identifier: 07640149381115
• UDI-Public: (01)07640149381115(11)201119
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K183364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: Other
• Device Model Number: 301.100.000
• Device Catalogue Number: 301.100.000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown