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

Model Number BELLAVISTA 1000E US 17,3" VENTILATOR

Device Problems Defective Alarm (1014); Mechanical Problem (1384)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

H3: 81 other - 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.H3 other text : device not returned yet.

Event Description

It was reported to vyaire medical problem with bellavista1000e us in which psv target (spontaneous volume guarantee) ventilation alarming continuously while on a patient.Patient was on pc/simv target (synchronized intermittent mandatory ventilation) initially for about the first 10 hours.This was a complex patient with likely bpd (borderline personality disorder) who did not like being intubated.They felt that the patient was badly synchronize with the ventilator, so they changed him to psv target.The patient was absolutely more comfortable, but the alarms continued to be an issue.Furthermore, there was no patient harm reported associated with this event.

Manufacturer Narrative

Results of investigation: vyaire medical was not able to verify the customer complaint.The suspect device was not returned for investigation.However, log file analysis tool was utilized.Exact issue is not clear as no further updates available from customer including the trend files requested by the vyaire technical support.No hw failures visible on logs.The root cause is not determinable.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs sankt gallen 9470 ; SZ 9470
• Manufacturer (Section G): TECHNOCOM SYSTEMS SDN BHD; plo 1, jalan firma 1, kawasan; perindustrian tebrau 1; johor bahru 81100 ; MY 81100
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17079684
• MDR Text Key: 316694306
• Report Number: 3004553423-2023-01885
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388879
• UDI-Public: (01)07640149388879(11)20190101
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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 US 17,3" VENTILATOR
• Device Catalogue Number: 301.100.130
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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