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

Model Number VELA

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

Patient Problem No Patient Involvement (2645)

Event Date 07/18/2016

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.(b)(4).At this time, carefusion has not received the suspect component for evaluation.

Event Description

The customer reported unresponsive touchscreen and delamination on the vela ventilator.The customer reported no patient involvement or allegation of patient harm.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis laboratory received the suspect component, a vela front panel assembly, and evaluated the device.An evaluation of the component duplicated the reported issue and isolated the issue to fluid ingress.

• 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: 5934872
• MDR Text Key: 54151981
• Report Number: 2021710-2016-04363
• 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: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2016

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
• Device Catalogue Number: 16532-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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