MAUDE Adverse Event Report: VYAIRE MEDICAL BELLAVISTA 1000 US; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	BELLAVISTA 1000 US
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The suspect device has not been returned for investigation.However; logs were analyzed and confirmed per flow chart, fc001 insp block needs to be replaced.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device has not been returned for evaluation.
Event or Problem Description
It was reported to vyaire medical that logs were giving tf 388.No patient involvement was reported.
Additional Manufacturer Narrative
Device evaluation: g6, h2, h6, and h11.Results of investigation: investigation on affected part on similar cases came to conclusion that the regulated pressure remains above the alarming threshold for flow rates of up to 3 lpm at supply pressures lower than 4 bar.The acceptance threshold as per the new alarm criterion introduced with software v6.0.1800.0 is 1 lpm.This leads to the conclusion that this pressure regulator is defective.A quote for insp block was sent.Root cause failure: defective o2 pressure regulator.

• Brand Name: BELLAVISTA 1000 US
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): TECHNOCOM SYSTEMS SDN BHD; plo 1, jalan firma 1, kawasan; perindustrian tebrau 1; johor bahru ; MY
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18983893
• Report Number: 3013421741-2024-00064
• Device Sequence Number: 19556869
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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 1000 US
• Device Catalogue Number: 301.100.030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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