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

Model Number	301.100.130
Medical Device Problem Codes	Failure to Deliver (2338); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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
Complainant reported the device experienced multiple technical failures; 300- device in failsafe and 316- failure to deliver therapy.Complainant did not report patient involvement.
Additional Manufacturer Narrative
The customer provided the device log files for review, which confirmed the presence of the reported alarms.Based on the findings, the customer was advised to replace the inspiration block to address the reported issue.A request was made for the defective component to be returned for further evaluation; however, it has not been received at this time.

• 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: 23794050
• Report Number: 3013421741-2025-01848
• Device Sequence Number: 18755294
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701(11)200509
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/25/2025

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: 301.100.130
• Device Catalogue Number: 301.100.130
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2020
• 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