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 03/22/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.However, vyaire medical technical support went on-site to gather the unit logs.Initial analysis, confirmed unit no o2 dosing error.Performed gas path test, gathered logs and trending data and re-evaluate logfile.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 bellavista1000 us having low o2 dosing and no o2 supply alarms.The unit ventilation keeps on running while the patient is in extracorporeal membrane oxygenation (ecmo) ventilator setting.It was confirmed by the customer that the patient was removed from the ventilator and no patient harm is associated with the event.

Manufacturer Narrative

Results of investigation: the suspect device was not returned for investigation.Vyaire medical was unable to established the exact root cause but most likely, it is due to a defective o2 pressure regulator, a restriction of the p2 regulator hole caused by injection molding deburrs during manufacturing.Vyaire medical representative performed o2 gas path test and initiated inspiratory block replacement.Unit worked properly according to manufacturers specifications.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11673364
• MDR Text Key: 247695491
• Report Number: 3004553423-2021-00958
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183(11)20190620
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• 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