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 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported screen delamination while using the vela ventilator.The customer reported the touchscreen was found to be non-reponsive with no alarms.The issue occurred during testing and there is no report of patient involvement is associated with the event.

Manufacturer Narrative

The customer reported the suspected front panel assembly is not available for evaluation.Due to the lack of material for evaluation, no verification of the allegation can be completed and no definitive root cause of failure determined.

• 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: 5292008
• MDR Text Key: 33951745
• Report Number: 2021710-2015-02450
• 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: 11/16/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• 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