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

Model Number BELLAVISTA 1000

Device Problem No Flow (2991)

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

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.However, by looking at the log file and o2 gas path test screenshots provider by the customer the "flow o2" reading in the test was not 0, the o2 dosing valve is leaking.No root cause has been determined at this time, since the investigation is still ongoing.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 1000 alarmed 379 "no o2 dosing possible".The customer confirmed that there was no patient involvement from the reported event.

Manufacturer Narrative

Result of investigation: it was determined that the root cause of the issue was the leaking o2 dosing proportional valve.O2 path self test is failing due to leaking o2 dosing proportional valve.As a resolution o2 dosing valve needs to be replaced.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: 11599984
• MDR Text Key: 244184186
• Report Number: 3004553423-2021-00926
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149380019
• UDI-Public: (01)07640149380019
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• 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: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1