MAUDE Adverse Event Report: VYAIRE MEDICAL INC BELLAVISTA 1000 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1000E

Device Problems Obstruction of Flow (2423); Pressure Problem (3012); Protective Measures Problem (3015)

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

Event Date 12/18/2020

Event Type  Injury  

Event Description

Bella vista vent was alarming "circuit occlusion" and prematurely terminating breaths on a paralyzed patient.This is a recurring issue with this ventilator when ventilating severely ill patients on volume targeted pressure ventilation.The ventilator circuit was not kinked or occluded.High pressure alarm was increased, and p insp max was raised to 50 cmh2o.Vent was still alarming occlusion and prematurely terminating breaths.The ventilator was then switched out of target ventilation and into conventional v-ac where the patient began ventilating with peak pressures of 40 and under.Patient was prone and on a nimbex drip.A short time later, the vent mode was switched back to target ventilation and it immediately started alarming "circuit occlusion again".The mode was immediately switched back to v-ac and it began alarming volume low due to high pressure limit.At this point, the vent mode was changed to p-ac and the ventilator was switched out with a different brand.Fda safety report id # (b)(4).

• Brand Name: BELLAVISTA 1000 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; mettawa IL 60045 3420
• MDR Report Key: 11100458
• MDR Text Key: 224854947
• Report Number: MW5098596
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000E
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO