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

Model Number	BELLAVISTA 1000E US 17,3 VENTILATOR
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3:81 other: the suspect device has not been return for investigation.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.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the bellavista1000e us 17,3" ventilator had an error message: "bellavista detected a user interface issue - decommission bv" screen.Furthermore, patient was transferred to alternative ventilation and no harm associated with the event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical field service representative went onsite to check and troubleshoot the device.The root cause was determined due to software issue.Most likely it is caused by ui overload.Investigations performed on similar cases by imt proved that this failure can be reproduced in the lab and the ventilation keep continuing with the last applied setting.This failure classified as "permanent apphang while device in standby mode".As a resolution, software bug fix improvements will be implemented on next sw release.Vyaire medical fsr ran verification per instruction from support.All tests passed required criteria.Unit is fully operational & available to service.

• 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 81100 ; MY 81100
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 19056729
• Report Number: 3013421741-2024-00072
• Device Sequence Number: 15312400
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2024

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: BELLAVISTA 1000E US 17,3 VENTILATOR
• Device Catalogue Number: 301.100.130
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 04/06/2024
• Supplement Report FDA Received Date: 08/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown