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

Model Number	301.100.000
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
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.The device was not returned for evaluation; however, the device log files were provided to zoll technical support for review.The log review observed abnormal entries of the power button pressed and the power button released.These entries indicate that the power board could have contributed to the customer's observation.As a result, the technical support-initiated warranty replacement for the power board to be replaced.
Event or Problem Description
The customer reported that the ventilator shutdown automatically while in use.No patient harm was 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 ; 26125 n. riverwoods blvd; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 25184279
• Report Number: 3013421741-2026-00202
• Device Sequence Number: 10542966
• Product Code: MKJ
• UDI-Device Identifier: 07640149381115
• UDI-Public: (01)07640149381115(11)211129
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K183364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2026

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: 301.100.000
• 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: 04/26/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown