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

Model Number BELLAVISTA 1000

Device Problems Increase in Pressure (1491); Blocked Connection (2888)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

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 Description

The customer reported several high pressure and occlusion alarms with the bellavista 1000 while connected to a patient on aprv (airway pressure release ventilation) mode.For patient's safety, the end user replaced the unit with a backup ventilator.The customer confirmed that there was no patient harm associated with the reported event.Additionally, the unit was reported to be passing the circuit test while skipping steps.

Manufacturer Narrative

Result of investigation: technical team is suspecting that the root cause of the issue was due to user fault for not following instructions.Log files shows that the o2 supply pressure drops down to zero and triggered alarm 271 "o2 supply fail - no o2 dosing possible." no visible 388 alarm showed on logs.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: 11110856
• MDR Text Key: 226082745
• Report Number: 3004553423-2020-00753
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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?: Yes
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention