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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the ventilator triggered a technical failure 389 alarm while performing o2 gas path test.No patient involvement.
Additional Manufacturer Narrative
Some information was not provided and is unknown; therefore, a complete udi cannot be provided.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The customer provided the device logs for review.No hardware faults were identified, and o2 safety valve testing confirmed no leakage.During follow-up, it was determined that the o2 settings were not configured correctly during the initial test procedure.The customer was provided clarification on proper o2 configuration and test setup.Based on log review and successful completion of calibration, the unit is operating within specifications and is suitable to return to service.

• 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: 24345565
• Report Number: 3013421741-2026-00049
• Device Sequence Number: 9523224
• Product Code: CBK
• UDI-Device Identifier: 10190752197664
• UDI-Public: (01)10190752197664(11)240515
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 01/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2024
• 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