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

Model Number BELLAVISTA 1000 US

Device Problem No Flow (2991)

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

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.However, technical support analysed the log files and confirmed alarm report 151 "o2 concentration low"; 271 "o2 supply fail-no o2 dosing possible and 388 "no o2 dosing possible alarm" found o2 supply at 3.72 bar.It was suggested to replace the inspiration block and provide result.No root cause has been determined yet because the investigation is still on going.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 bellavista 1000 showing oxygen alarms 151 "o2 concentration low"; 271 "o2 supply fail-no o2 dosing possible and 388 "no o2 dosing possible alarm".Customer stated they pulled the units off patient and transfer on another ventilator (espirit).There is no harm noted to the patient with this event.

Manufacturer Narrative

Result of investigation: it was determined that the root cause of the issue was the defective o2 pressure regulator.Most likely restriction of the p2 regulator hole caused by injection molding deburrs during manufacturing.Alarm 388 and 271 at 3.6 to 3.8 bar.It compromises the dynamic behavior of the pressure regulator.This leads to overshooting of the internal o2 pressure "press o2 regulated", triggers the alarm "technical failure 388 - no o2 dosing possible" and leads to the o2 gas path shut-down by the bellavista software (safety procedure).

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11727721
• MDR Text Key: 247681313
• Report Number: 3004553423-2021-00967
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183(11)201015
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000 US
• Device Catalogue Number: 301.100.030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention