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

Model Number VELA COMP D

Device Problems Delamination (2904); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Carefusion complaint number (b)(4).In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.Carefusion has yet to receive the sample for evaluation.(b)(4).

Event Description

The customer stated that this unit has a non-responsive, delaminating screen.There was no patient involvement at the time of the event.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis lab evaluated the front panel and was able to reproduce the reported event of there being fluid ingress on the panel screen, and when powering on screen calibration was unable to be performed.This issue 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 ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5445698
• MDR Text Key: 38701655
• Report Number: 2021710-2016-03164
• 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: 01/25/2016

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 D
• Device Catalogue Number: 16532-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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