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

Model Number	301.100.000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k) # - the device is a similar device marketed in foreign countries and is not marketed under the 510k.Some information was not provided and is unknown; therefore, a complete udi cannot be provided.Zoll medical corporation has not received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
The ventilator in use for a tracheostomised patient suddenly ceased operation and displayed a ?user interface issue? alarm on the screen.Immediate manual ventilation using an ambubag was initiated by the nurse in charge who witnessed the incident.The respiratory therapist promptly replaced the ventilator with another device.The patient remained stable throughout the event, with no episodes of oxygen desaturation or signs of respiratory distress observed.No further complications were noted following the incident.

• 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: 25201172
• Report Number: 3013421741-2026-00223
• Device Sequence Number: 18662773
• Product Code: CBK
• UDI-Device Identifier: 07640149381115
• UDI-Public: (01)07640149381115(11)171221
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 301.100.000
• Device Catalogue Number: 301.100.000
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2017
• 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