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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by a zoll-field service engineer (fse) at the customer site.The customer's report was duplicated and attributed to a defective inspiration block.The inspiration block was replaced to remedy the report.G4.Pma / 510k# - the device is a similar device marketed in foreign countries and is not marketed under the 510k.
Event or Problem Description
The customer reported that the ventilator exhibited technical failure 388, "no o2 dosing possible" alarm.There was no patient involvement reported.

• 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,; johor bahru; johor bahru ; MY
• MDR Report Key: 24748682
• Report Number: 3013421741-2026-00132
• Device Sequence Number: 8779592
• Product Code: CBK
• UDI-Device Identifier: 07640149381115
• UDI-Public: (01)07640149381115(11)200226
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: 03/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• 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