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

Model Number BELLAVISTA 1000

Device Problem Leak/Splash (1354)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).The suspect device has not been returned for evaluation.However, the log file and screen shot of service screen was reviewed.It was seen that the o2 (oxygen) path self-test is failing due to leaking o2 safety valve.As a resolution, o2 safety needs to be replaced.Results of investigation: vyaire medical determined root cause as due to leaking o2 safety valve.

Event Description

It was reported to vyaire medical that the bellavista 1000 ventilator alarmed technical failure 389 (no dosing possible).The customer confirmed that there was no patient involvement associated with the reported event.

• 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: 11665814
• MDR Text Key: 245401391
• Report Number: 3004553423-2021-00954
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149380019
• UDI-Public: (01)07640149380019
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000
• Device Catalogue Number: 301.100.000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2021
• 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