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

Model Number BELLAVISTA 1000E 17,3" BASIC VENTILATOR

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that the bellavista1000e us had an error 305 - "communication to cfb disconnected" and the unit does not turn off.Furthermore, there was no patient associated with this issue.

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H3: 81 other - the suspect device has not been return for investigation.Furthermore, no root cause has 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.

• 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18539443
• MDR Text Key: 333269864
• Report Number: 3004553423-2024-02138
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149380026
• UDI-Public: (01)07640149380026
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2024

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 17,3" BASIC VENTILATOR
• Device Catalogue Number: 301.100.100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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