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

Model Number BELLAVISTA 1000

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 to vyaire medical that the bellavista 1000 ventilator is causing increased artifact during eeg (electroencephalogram) test.It does not matter if the patient is on invasive, non-invasive or high flow mode.If the machine is on or turned off, it causes artifact.The issue happened during use on 11 different patients.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Device evaluation update: g3, g6, h1, h2, h3, h6 and h10 results of investigation: the suspect device was not returned for investigation.However, vyaire medical made recommendations to avoid similar issues in the future.Activating the nihon kohden software's 60hz noise filter, set up the leads so that they are not running across the patient, in contact with any metal objects, near the camera equipment or near the patient breathing circuits, and finally, after the electrodes have been connected to a patient, perform an electrode impedance check to ensure that the impedances are consistent, with only minor variations across all electrodes and less than 20k ohms.Root cause of failure was due to the noise in the charts was pointed out as a thickening of the traces and similar noise was recreated during experiments when the eeg leads were near the heated breathing circuits, humidifier or power line.The unit did not cause interference when the eeg was configured properly.This complaint will be included with on-going trending analysis.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
• Manufacturer (Section G): TECHNOCOM SYSTEMS SDN BHD; plo 1 jaian firma 1; kawasan perindustrian tebrau 1; johor bahru, 81100 ; MY 81100
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11732578
• MDR Text Key: 247524953
• Report Number: 3004553423-2021-00993
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1