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

Model Number VELA

Device Problem Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2015

Event Type  malfunction  

Event Description

The following reported event originated from a foreign distributor in (b)(6).The distributor reported that the "touchscreen is delaminating and thus non-responsive." no patient involvement.

Manufacturer Narrative

(b)(4).Per information provided by the distributor, carefusion technical support determined that the front panel assembly was defective.A replacement front panel assembly was shipped to the distributor.A returned goods authorization (rga) number was also issued for the return of the alleged faulty front panel assembly for evaluation.As of april 22, 2015 the alleged faulty front panel assembly has not been received.

Manufacturer Narrative

Failure analysis (fa) lab received a vela front panel.Fa visually inspected the and noted fluid ingress spots in screen.Fa installed the front panel in a known good unit.The touch screen was completely irresponsive and could not be calibrated.

• Brand Name: VELA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jacquiline tamale ; 7607787234
• MDR Report Key: 4731124
• MDR Text Key: 5749802
• Report Number: 2021710-2015-00810
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K032451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: No Information
• Type of Report: Initial,Followup
• Report Date: 03/24/2015

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
• Device Catalogue Number: 16532-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Initial Date Manufacturer Received: 03/24/2105
• Initial Date FDA Received: 04/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: Reuse
• Patient Sequence Number: 1