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

Model Number BELLAVISTA 1000

Device Problem Calibration Problem (2890)

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

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

The vyaire representative ran the unit at different percentage of fio2, and the reading was always in line with the value set.The o2 sensor was then replaced and two-point calibrated without problems.The unit was again run at different steps of oxygen without problems.Analysis of the log files shows the alarm occurred 50x since the end of february, and two-point calibration was only done twice.However, the alarm is no longer visible after sensor replacement and calibration.It is suspected that the o2 sensor is defective.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It is reported to vyaire medical that the bellavista experienced alarm 221 - "oxygen sensor requires calibration" while connected on a patient.The customer confirmed the patient was transferred to another ventilator with no patient harm noted.

Manufacturer Narrative

Result of investigation: vyaire medical was able to verify the customer's reported issue.Bench testing revealed a most likely local elements as consequence of microscopic leakages due to insufficient glue sealing of the contact wire glue holes / possible hollows on the crossing of the cathode wire and the glue in the front area.The root cause was attributed to o2 sensor long-life defective.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: 11721240
• MDR Text Key: 247213763
• Report Number: 3004553423-2021-00976
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention