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

Model Number	301.100.030
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Customer stated that the occlusion error will not go away while being used on a patient.There was no patient harm reported.
Additional Manufacturer Narrative
A field service engineer (fse) went on site to evaluate the device.The device logs were returned to technical support, and they indicated that the device had not been calibrated since march of 2024 and identified multiple occlusion alarms.Technical support recommended that the fse perform a full preventive maintenance (pm) and monitor if the issue recurred.After the full pm and verification testing, the reported issue could not be replicated.The occlusion alarms that the user experienced were likely due to the device being out of calibration.

• 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: 24210202
• Report Number: 3013421741-2026-00030
• Device Sequence Number: 9624625
• Product Code: CBK
• UDI-Device Identifier: 10190752197664
• UDI-Public: (01)10190752197664(11)231207
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 301.100.030
• Device Catalogue Number: 301.100.030
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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