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

Model Number BELLAVISTA 1000E

Device Problem Computer Operating System Problem (2898)

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

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.However, screen shot of service screen has been sent and analyzed by technical support.It was suspected that the mainboard needs to be replaced but on the other hand they couldn't think of any reason how the settings should have changed no further details received from the user.No root cause has been determined yet because the investigation is still on going.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 accompanied by a high priority visual/audible alarm with the bellavista 1000e.Ventilation continued, but the mode seemed to have changed from psv (pressure support) to controlled based on the connected patient's chest movement and reaction.The end user restarted the device and went through setup again.The patient was nervous, but unharmed.

• 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: 10543819
• MDR Text Key: 207341973
• Report Number: 3004553423-2020-00661
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 301.100.100
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/16/2020
• 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