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

Model Number VELA

Device Problems Delamination (2904); Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Carefusion technical support shipped the distributor a replacement front panel assembly.A returned goods authorization (rga) number was also issued for the return of the alleged faulty front panel assembly for evaluation.As of august 6, 2015, carefusion has not received the alleged faulty front panel assembly.

Event Description

This complaint originated from a foreign distributor in (b)(6).The distributor reported the following: "front panel became non-responsive.Delamination evident on bottom right and [ ] can't access hours or software version.".

Manufacturer Narrative

Device code: no display or display failure.Failure analysis lab received a vela front panel assembly.The vela front panel assembly was visually inspected.Fluid ingress spots in screen were noted.The vela front panel assembly was installed in known good unit.The touch screen was irresponsive and could not be calibrated.This reported event considered a known issue addressed with an internal action.

• Brand Name: VELA VENTILATOR
• Type of Device: VENTILATOR, CONTINUIOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION; yorba lind CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 8473628056
• MDR Report Key: 4991626
• MDR Text Key: 22757087
• Report Number: 2021710-2015-01342
• 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: distributor,foreign
• Reporter Occupation: No Information
• Type of Report: Followup
• Report Date: 07/08/2015

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: 16532-04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• 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