MAUDE Adverse Event Report: IMTMEDICAL AG BELLAVISTA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number BELLAVISTA 1000

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Dyspnea (1816)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Initial analysis of the log files reveals no technical failures.Also, initial analysis of the trending data reveals no fluctuation of oxygen, and no fluctuation of flow during the whole hfot period.No root cause has been determined at this time, since the investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the bellavista 1000e was set with flow of 50 and fio2 (fraction of inspired oxygen) of 50% for hfot (high-flow oxygen therapy).However, it only generated flow of 9.5 and achieved fio2 of 50%.The patient connected to the device struggled to breathe and was transferred to a backup ventilator (flow of 50 and fio2 of 60%) with no problems.

Manufacturer Narrative

Result of investigation: vyaire medical has checked the suspect device.Investigation revealed no failure or issue with the ventilator.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11289254
• MDR Text Key: 230677859
• Report Number: 3004553423-2021-00828
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149380019
• UDI-Public: (01)07640149380019
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000
• Device Catalogue Number: 301.100.000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 06/27/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention