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

Model Number VELA

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591); Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: the carefusion failure analysis laboratory received the suspected component, a vela turbine assembly, and evaluated the device.An evaluation of the component could not duplicate the reported issue of "motor fault", because the turbine was found in a "vent inop" (vent inoperable condition) and isolated the issue to the turbine interface printed circuit board assembly (pcba).If additional information becomes available, it will be submitted in a follow-up report.

Event Description

The customer reported that the ventilator has a non-responsive, delaminated touch screen.The customer replaced the front panel and the ventilator alarmed "vent inop" and the events log indicated "motor fault." the customer replaced the turbine with that of another good, known working ventilator and the unit performed correctly.There was no patient involvement reported.

• 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 ; 7149227830
• MDR Report Key: 5743180
• MDR Text Key: 48259435
• Report Number: 2021710-2016-03926
• 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
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA
• Device Catalogue Number: 16532-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• 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