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

Model Number VELA

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

Any additional information that is provided by the customer will be included in a follow-up report.(b)(4).Field service representative report: a carefusion field service representative (fsr) went onsite to evaluate the device.The fsr identified that the turbine requires replacement to resolve the reported issue.The fsr has ordered a replacement part and is awaiting delivery of the turbine in order to complete the repair and evaluation of the device.Once a final evaluation of the device is complete, a supplemental report will be submitted.

Event Description

The customer reported that vela ventilator has an audible gurgling sound and a burning smell during patient use.The customer reported that the device was switched to another ventilator and there was no harm/injury on the patient.

Manufacturer Narrative

The carefusion failure analysis laboratory received the suspect component, a vela turbine, and evaluated the device.An evaluation of the component found a grinding noise coming from the turbine during operation, but no burning smell was noted.The rear and/or front bearing was failing and the turbine interface printed circuit board assembly (pcba) became corrupted and failed.

• 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
• MDR Report Key: 6065209
• MDR Text Key: 58700334
• Report Number: 2021710-2016-04764
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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