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

Model Number BELLAVISTA 1000

Device Problem Computer Software Problem (1112)

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

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

The log file was received but unable to identify if it is a software bug or a hardware issue with the o2 detector on the mainboard.The root cause could not be determined as of this time.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 bellavista 1000 was getting user interface error during use on a patient.The patient was then transferred to an alternative ventilator with no harm or injury.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h6 and h10.Results of investigation: analysis of the log file reveals a software bug in improved internal o2 sensor communication handling found in v6.0.1600.0.This issue was resolved with v6.0.1700.0.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: 11556252
• MDR Text Key: 241838119
• Report Number: 3004553423-2021-00917
• 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: 02/25/2021

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
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention