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

Model Number BELLAVISTA 1000 US

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H3:81 other: the suspect device has not been returned for investigation.However, vyaire technical support (ts) requested pictures of the screen and approved for obf replacement.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.

Event Description

It was reported to vyaire medical that the bellavista1000 us had the following screen issues: 1.Screen is quite dark, 2.Screen is only partially viewable, with several missing or partially missing components, and 3.Screen has shadow screen in the background of a different screen.Furthermore, there was no patient involvement associated with the event.

Manufacturer Narrative

Results of investigation: the suspect device was not to vyaire medical for evaluation.The root cause was determined due to touch screen - defective.The reported failure was confirmed and isolated to internal failure of the user interface assembly bellavista 1000 p/n 030.100.060 rev c s/n (b)(6).As a resolution, vyaire medical tech support initiated parts replacement.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs sankt gallen 9074 ; SZ 9074
• 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: 17814807
• MDR Text Key: 324230802
• Report Number: 3004553423-2023-02001
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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