MAUDE Adverse Event Report: IMTMEDICAL AG BELLAVISTA 1000; VENTILLATOR, CONTINOUS, FACILITY USE

Model Number BELLAVISTA 1000

Device Problem Leak/Splash (1354)

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

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.However, after reviewing the logs and pictures, vyaire technical support indicated that it is clear that blower and main electronics are affected.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

A biomedical hospital staff reported to vyaire medical that the bellavista 1000 is presenting technical failure alarm 401 - inspiration valve or device leaky.At the time of starting to carry out the tests, the engineer noticed a smoke coming out of the interior.Motherboard found damaged near blower connector.Furthermore, the customer confirmed that there was no patient involvement reported.

Manufacturer Narrative

Results of investigation: the suspect device was not returned for investigation.Vyaire medical findings indicated that most likely, the failure is due to the blower electronics.However, exact root cause is not determinable.Blower driving hw on the main electronics also damaged.Vyaire medical will initiate blower replacement.

• Brand Name: BELLAVISTA 1000
• Type of Device: VENTILLATOR, CONTINOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11758085
• MDR Text Key: 251740417
• Report Number: 3004553423-2021-01000
• 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,health pr
• Type of Report: Initial,Followup
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• 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