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

Model Number	301.100.130
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).D4: complete udi# was not provided by end user.H3: 81 other - 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 the bellavista1000e us 17,3" ventilator display bluescreen during use.No patient harm was reported, as they were able to swap the patient onto a new vent.
Additional Manufacturer Narrative
Results of investigation: the original complaint was duplicated.The uut was tested and found to have a failed component, the msata drive.Disposition: the unit bellavista 1000e main electronic assembly sn (b)(6) will be placed on hold.

• Brand Name: BELLAVISTA
• 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: 20386015
• Report Number: 3013421741-2024-00475
• Device Sequence Number: 8008355
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 301.100.130
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 12/14/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown