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

Model Number	BELLAVISTA 1000E US 17,3 VENTILATOR
Medical Device Problem Codes	Mechanical Problem (1384); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H10: the suspect device has not been return for investigation.However, log shows nothing looks out of the norm in the o2 gas path test.During the scale point calibration test, unit gets constant 61 lpm which is within normal range.Asked customer to send a screenshot of the adcs screen.Furthermore, no root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the bellavista1000e us 17,3" ventilator is giving tf 401 (inspiration valve or device leaky) and 316 (blower failure).Furthermore, there was no patient associated with the event.
Additional Manufacturer Narrative
Results of investigation: the suspect device was not returned to vyaire medical for evaluation.The root cause was determined to be due to inspiration valve defect.Log entries shows that the blower and the blower controlling hw is functioning properly.As a resolution, the inspiration block and the unit mainboard are replaced, and the issue resolved.

• Brand Name: BELLAVISTA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): TECHNOCOM SYSTEMS SDN BHD; plo 1, jalan firma 1, kawasan; perindustrian tebrau 1; johor bahru 8100 ; MY 8100
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 19078798
• Report Number: 3013421741-2024-00078
• Device Sequence Number: 17811813
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: Health Professional
• Device Model Number: BELLAVISTA 1000E US 17,3 VENTILATOR
• Device Catalogue Number: 301.100.130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown