MAUDE Adverse Event Report: VYAIRE MEDICAL BELLAVISTA 1000E US 17,3 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	BELLAVISTA 1000E US 17,3 VENTILATOR
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not 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 bellavista1000e us 17,3" ventilator had tf 271 - "o2 supply fail - no o2 dosing possible.It occurred once while on a patient during multiple alarms such as 258 - disconnection exhalation valve, 251 - disconnection and 113 - pressure low.No patient harm was reported.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h6, and h11.Results of investigation: from the log data, the cause of the initial tf271 alarm remains undetermined, as the device was set to deliver 80% oxygen with an o2 supply pressure of 3.62 bar.As a precautionary measure, the customer recalibrated the device to minimize the likelihood of recurrence.Unit functioned as designed.No failure detected.

• Brand Name: BELLAVISTA 1000E US 17,3 VENTILATOR
• 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 ; 2402760001
• MDR Report Key: 19353818
• Report Number: 3013421741-2024-00115
• Device Sequence Number: 7528781
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701(11)20201509
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown