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

Model Number BELLAVISTA 1000 US

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

A vyaire field service representative (fsr) went onsite and evaluated the ventilator.Fsr verified ventilator was working properly.Calibrated o2 sensor, performed circuit test, tested ventilation, and verified alarms are working properly.No root cause has been determined at this time since the investigation is still ongoing.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 us was tested and placed on intubated patient.The device was set in volume assist control mode with 18 bpm set rate.The respiratory therapist noticed that the bpm reading was slowly drifting down to 1 but the patient received breaths from the ventilator.They swapped the ventilator into another bellavista 1000 and bpm readings worked correctly.The customer confirmed that there was no patient harm reported from this even.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h6 and h10.Result of investigation: no device problem detected.Machine tested by vyaire field service engineer.Error could not reproducible.Verified ventilator was working properly.Calibrated o2 sensor, performed circuit test, tested ventilation, and verified alarms are working properly.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11437118
• MDR Text Key: 238610811
• Report Number: 3004553423-2021-00884
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183(11)20201228
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000 US
• Device Catalogue Number: 301.100.030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention