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

Model Number VELA COMP

Device Problems Fluid/Blood Leak (1250); Delamination (2904)

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

Event Date 06/15/2015

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.The front panel was installed into a functional vela unit and powered in service mode for testing.Performed touch screen calibration and the touch screen was responsive to input.The reported problem of unresponsive touch screen was unable to be duplicated.There is visible water ingress into the resistive touch screen.No patient involvement was indicated.This is considered a known issue and addressed with an internal action.The vela front panel assembly was scrapped.

Event Description

The customer indicated the screen is delaminated.Fluid ingress, inactive touch screen.Per attached warranty form, the device was not on a patient.The issue was found during testing.Fluid ingress, touch screen inactive.

Manufacturer Narrative

(b)(4).Remove ps within the catalog number on supplement 001.

• 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: 5537574
• MDR Text Key: 41776231
• Report Number: 2021710-2016-03421
• 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: 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

• Date FDA Received: 03/31/2016
• 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: 16532-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other