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

Model Number VELA COMP D

Device Problems Display or Visual Feedback Problem (1184); Device Emits Odor (1425); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification number is (b)(4).(b)(4).The device has been received and is currently under investigation.A follow-up report will be made once the results of investigation are complete.

Event Description

The customer reported when the vela ventilator is turned on, the device alarms, the screen goes blank and has burning smell.The customer reported no patient involvement or allegation of patient harm.

Manufacturer Narrative

The carefusion failure analysis lab (fa lab) received the vela main printed circuit board assembly (pcba) and harness.Visual inspection was conducted and found burned j16 port from the pcba on pin 12.Pin 11 on j16 was shorted and a burn mark was found on the harness.The reported issue was duplicated and the cause of the burning pin 12 was cause by a short at the pin.

• Brand Name: VELA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 2627587805
• MDR Report Key: 5182169
• MDR Text Key: 29970292
• Report Number: 2021710-2015-02056
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA COMP D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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