MAUDE Adverse Event Report: IMTMEDICAL AG BELLAVISTA 1000 / BELLAVISTA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number BELLAVISTA 1000

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

Vyaire bellavista 1000 ventilator - experienced failure of inspiration block, machine was brand-new.Replacement parts not readily available because vyaire has already had to replace more than they produced.I cannot understand how this issue has not generated a safety recall.I have heard (from manufacturer) that they had to source 3'rd party manufacturers to produce parts due to increased demand so feel this maybe contributing to the inspiration block failure.Fda safety report id # (b)(4).

• Brand Name: BELLAVISTA 1000 / BELLAVISTA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG
• MDR Report Key: 11613133
• MDR Text Key: 243978541
• Report Number: MW5100538
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• 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: 301.100.030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1