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

Model Number BELLAVISTA 1000E

Device Problem Computer Operating System Problem (2898)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device 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 blue screen issue with the bellavista 1000e and cannot turn off the ventilator even pressing the hard power off.There was no information of patient involvement reported from this event.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: the exact root cause is not determinable.Most likely the issue is caused by a hardware issue on the epc.Despite many tests performed by imt ag on similar returned parts, the issue was still not reproducible.Investigation will be continued under (b)(4).As the failure rate is within the expected range as per our risk files, decided to close this complaint.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11554940
• MDR Text Key: 244383152
• Report Number: 3004553423-2021-00915
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388879
• UDI-Public: (01)07640149388879(11)20200611
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000E
• Device Catalogue Number: 301.100.030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1