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

Model Number VELA

Device Problems Failure to Calibrate (2440); Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.(b)(4).The customer reported the suspect component is available for analysis and an return good authorization (rga) has been issued.At this time, carefusion has not received the suspect component for evaluation.

Event Description

The customer reported while using the vela ventilator; the touchscreen is out of calibration and the unit has signs of delamination on the bottom right-hand corner of the screen.The customer reported the point of contact is about three centimeters higher, making it impossible to access the screen calibration menu.The customer reported there is no patient involvement associated with the event.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis laboratory received the suspected front panel assembly for investigation.An investigation was performed and identified the root cause of the reported issue was due to fluid ingress within the assembly.This issue will be internally investigated within carefusion.

• 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: 5724735
• MDR Text Key: 47455663
• Report Number: 2021710-2016-03873
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2009
• 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