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

Model Number VELA COMP D

Device Problem Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In the event the device is received for evaluation or additional information is provided a follow-up report will be submitted.At this time, carefusion has not received the device from the customer.(b)(4).

Event Description

The customer stated that the screen is delaminated on bottom right of the screen and it non-responsive to touch.The customer has reported that this was found during testing and there was no patient involvement.

Manufacturer Narrative

Results of investigation: the suspect front panel assembly was returned to the carefusion failure analysis lab for evaluation.The results of the investigation confirmed fluid ingress on the touch screen.The front panel was installed onto a known good unit where the issue of the unit not responding to touch was unable to be reproduced, however fluid ingress can cause an intermittent failure.This is considered a known issue and is being addressed through an internal investigation.

• 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 ; 8473628056
• MDR Report Key: 5246612
• MDR Text Key: 32160441
• Report Number: 2021710-2015-02286
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K093094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA COMP D
• Device Catalogue Number: 16532-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• 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