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

Model Number BELLAVISTA 1000

Device Problem Unexpected Shutdown (4019)

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

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).Vyaire received logs and it shows epc has suddenly stopped logging on (b)(6) 2021 at 02:30:21.The cfb logs are clearly showing that the ventilation has continued with the last applied settings.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

The customer reported that the bellavista 1000 shutdown while on patient use.When they checked the unit the screen shows service password required.They swapped the unit with another ventilator and confirmed that there was no patient harm associated from this event.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h6 and h10.Result of investigation: exact root cause not established.It is most likely that the epc is causing the issue.The epc has suddenly stopped logging on 03/23/2021 at 02:30:21.The cfb logs are clearly showing that the ventilation has continued with the last applied settings (vent state-1) and the vent has alarmed as designed (buzzer beep tone, red alarm lights and nurse call).

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11682593
• MDR Text Key: 246012079
• Report Number: 3004553423-2021-00953
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183(11)200622
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: 301.100.030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention