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

Model Number	301.100.030
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
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 the device alarmed technical failure 389, no o2 dosing possible.There was no patient involvement related to the reported malfunction.
Additional Manufacturer Narrative
The device log files were provided to technical support for evaluation.It was further clarified that the reported alarm occurred during the o2 valve offset calibration.The log files confirmed the presence of the reported alarm.This alarm is typically associated with a leak; however, no leak was observed in the log files and could not be confirmed with the customer.A review of the o2 gas path test results also showed no indication of a safety valve leak.The customer was advised to perform all calibrations and verification testing and confirmed that the reported alarm did not reoccur.It was determined that the device is operating as intended and no malfunction was observed.

• 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: 24586395
• Report Number: 3013421741-2026-00097
• Device Sequence Number: 9240085
• Product Code: CBK
• UDI-Device Identifier: 10190752197664
• UDI-Public: (01)10190752197664(11)240213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2024
• 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