MAUDE Adverse Event Report: CAREFUSION, INC VELA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number VELA

Device Problem Volume Accuracy Problem (1675)

Patient Problem Stacking Breaths (1593)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A field service representative went on site and evaluated the devices.He identified that the customer¿s maintenance and cleaning procedures for the exhalation valve assemblies was insufficient and causing the reported issues.The customer confirmed that they implemented a new cleaning procedure and this has resolved the issues.

Event Description

The customer reported volume issues on the inspiratory volume and exhaled volume but it was not verified with an external analyzer.This occurred on multiple ventilators with one ventilator experiencing breath stacking but at this time the customer does not know which ventilator experienced the breath stacking issue.These issues occurred while on a patient but the customer confirmed there was no serious patient harm or injury.

• Brand Name: VELA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5950484
• MDR Text Key: 54702514
• Report Number: 2021710-2016-04411
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA
• Device Catalogue Number: 16532-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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
• Patient Outcome(s): Required Intervention