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

Model Number VELA COMP D

Device Problems Image Display Error/Artifact (1304); Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification number is (b)(4).Any additional information that is provided by the customer will be included in a follow-up report.The device has not been received by carefusion.

Event Description

The customer reported while using the vela ventilator the front panel became non-responsive secondary to display panel delamination.The customer reported no patient involvement or allegation of patient harm.At this time, carefusion has not received the suspect device component for evaluation.

Manufacturer Narrative

Per results of investigation, the carefusion failure analysis (fa) lab received the suspect front panel assembly and installed in on a known good vela ventilator unit.The panel was inspected and found "liquid ingress" on it.The unit was powered on and the reported complaint of the front panel becoming non-responsive due to delamination was duplicated.This issue will be internally investigated.

• 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: 5148666
• MDR Text Key: 28574490
• Report Number: 2021710-2015-01886
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/16/2015

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: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2012
• 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