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

Model Number BELLAVISTA 1000E

Device Problem Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

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 1000e us ventilator alarmed, shut off and stopped ventilating during use on a patient.The alarm message shows "user interface".The patient experienced bradycardia and desaturation.At this time, there is no information regarding remedial action taken by the healthcare facility.

Manufacturer Narrative

Results of investigation: analysis on the log file shows the ui failsafe with v6.0.1600.0 was due to photonic o2 sensor thread visible.As designed, ventilation continued (vent state-1) with last applied settings and all alarm lines were triggered (buzzer alarm, alarm leds and nurse call).This issue is resolved with version 6.0.1700.0.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: 11713042
• MDR Text Key: 246986484
• Report Number: 3004553423-2021-00973
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388879
• UDI-Public: (01)07640149388879(11)20200930
• Combination Product (y/n): N
• PMA/PMN Number: K183364
• 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: 03/29/2021

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 1000E
• Device Catalogue Number: 301.100.030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention