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

Model Number BELLAVISTA 1000

Device Problem Noise, Audible (3273)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire identification number: (b)(4).At this time, the suspected device and log file has not been returned for evaluation.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 that the bellavista 1000 is making an abnormal noise during functioning, heats up a lot, and stops working.It happened during patient use with no allegation of harm.However, intervention is unknown/not specified.

Manufacturer Narrative

Results of investigation: analysis on the log file shows that the noise was most likely due to the obstruction on the cooling fan which was identified and resolve by the customer.According to customer issue was not reproducible.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: 11746602
• MDR Text Key: 250580904
• Report Number: 3004553423-2021-00979
• 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: 04/02/2021

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: 301.100.000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1