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

Model Number VELA COMP

Device Problems Poor Quality Image (1408); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr was identified as requiring submission during a two year retrospective review.This complaint was opened as a duplicate to submit the mdr due to a pathway error.The initial report number was (b)(4).Failure analysis (fa) received a vela front panel assembly and conducted a visual inspection.Visible ingress moisture residue on the front display was noted.The front panel was installed into a functional vela unit for duplicating the reported problem.The display was powered in service mode and initialized patient-user displays and colors with no problems.Performed display calibration.The touch display interaction was successful and can be calibrated.The reported problem could not be duplicated but failed due to intermittent operation caused by ingress moisture between the membranes of the touchscreen.The failure was isolated to the touchscreen.This is considered a known issue and addressed with an internal action.The vela front panel assembly was scrapped.

Event Description

The customer indicated touch screen is not responding when touch.There is big spot on screen.Per warranty form the issue was found during maintenance.Received email from the customer indicating serial number is (b)(4) and that there wasn't any patient injury reported.They will send the faulty front panel to carefusion.

Manufacturer Narrative

Added missing the model name.

Manufacturer Narrative

(b)(4).

• 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: 5538202
• MDR Text Key: 41823773
• Report Number: 2021710-2016-03427
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K093094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/31/2016

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
• Device Catalogue Number: 16532-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2016; 04/06/2016; 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other