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

Model Number	301.100.030
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: h6.The device log files were provided to technical support for evaluation.The log analysis identified cfb log entries recorded on 3/17/26 during active ventilation.The log review further confirmed that although the display transitioned to a blue screen, the ventilator continued operating, indicating that ventilation was maintained during the event.A company fse (field service engineer) was dispatched to the customer site, and the main board was replaced.After replacement, the device was fully calibrated and passed all testing and was placed back in service.The removed main board was returned to zoll fa lab (failure analysis lab) for evaluation.The board was installed into a known working bellavista device and passed full functional testing without any abnormalities found.The reported malfunction was unable to be duplicated.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation, and this complaint is still under investigation.
Event or Problem Description
It was reported that while vent was in use on a patient, when the vent showed a blue screen and did not appear to be ventilating.No patient harm 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; perindustrian tebrau 1; johor bahru ; MY
• MDR Report Key: 24794226
• Report Number: 3013421741-2026-00125
• Device Sequence Number: 12921675
• Product Code: CBK
• UDI-Device Identifier: 10190752197664
• UDI-Public: (01)10190752197664(11)250123
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 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: 301.100.030
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2025
• 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