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

Model Number BELLAVISTA 1000

Device Problem Unexpected Shutdown (4019)

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

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device switched to ui failsafe mode.The customer indicated that ventilation stopped.However, per the log files, ventilation continued.Also, logs indicate communication error with internal o2 sensor.Software upgrade was recommended.

Event Description

The customer reported that the bellavista 1000 shut down during patient use, and the screen went black.After 10 seconds, it continuously alarmed visually and acoustically.The end user immediately changed the ventilator.No harm is associated with this incident.

Manufacturer Narrative

(b)(4).The root cause was determined to be due to a software bug in improved internal o2 sensor communication handling found in v6.0.1600.0.This issue is resolved with v6.0.1700.0.Customer to upgrade when available.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: 11732729
• MDR Text Key: 247530038
• Report Number: 3004553423-2021-00981
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183
• 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: 03/31/2021

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: 301.100.030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention