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

Catalog Number 301.100.101

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.However, analysis of the provided log files and trending data reveals that the reported behavior is visible with activate alarm 140 - "high rate" and oscillations in the flow curve respectively.The flow trigger was set at 0.5 lpm, what then caused auto-triggering effects.As such, the technical team suspects an o2 dosing valve problem.The customer has been requested to check if they can reproduce the behavior on a test lung, see if replacing o2 dosing valve fixes the problem, and send the exchanged o2 dosing valve for evaluation.No root cause has been determined.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 triggered additional breathing cycles during o2 suction maneuvers in which o2 concentration setting was higher than 80%.This led to a breathing frequency of 100 bpm.The patient connected to the device was transferred to a backup ventilator.However, it was confirmed that no harm was associated with the event.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h6 and h10.Result of investigation: it was determined that the root cause of the issue was mechanical component defect.There is a discontinuity in the o2 control valve characteristic.At a certain valve stroke, the flow suddenly jumps to a higher value when opening the valve.The issue was fully resolved with a new o2 dosing valve.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 10353796
• MDR Text Key: 201370972
• Report Number: 3004553423-2020-00619
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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 Catalogue Number: 301.100.101
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 09/12/2021
• Supplement Dates FDA Received: 10/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention