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

Model Number	301.100.000
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use, the device experienced a technical failure 316.Complainant indicated that there was no patient involvement in the reported issue.
Additional Manufacturer Narrative
G4: pma/510(k) # - the device is a similar device marketed in foreign countries and is not marketed under the 510k.The device was not returned to zoll medical corporation for evaluation.During the investigation it was noted that when the device was received at the distributor site, neither alarm could be reproduced.The device log files were returned to zoll technical support for review.The reported alarm was confirmed in the log files which typically indicates a small leak associated with the inspiratory valve.During calibration, it was observed that the device failed the leak calibration process which could indicate the inspiration block as the source of the leak.Technical support advised the customer to replace the inspiration block to resolve the reported issue.At this time, the customer has not placed an order for a new inspiration block; therefore, we are unable to definitively determine root cause.

• 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: 25174933
• Report Number: 3013421741-2026-00220
• Device Sequence Number: 15987181
• Product Code: CBK
• UDI-Device Identifier: 07640149381115
• UDI-Public: (01)07640149381115(11)201005
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 02/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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