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

Model Number VELA COMP D

Device Problem Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2015

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).Results of investigation: the carefusion failure analysis (fa) representative (rep) received the suspect front panel assembly for evaluation.The carefusion fa rep installed in on a known good unit and performed touch screen calibration, the touch screen was responsive to input.The carefusion fa rep was unable to duplicate the customer¿s alleged non-responsive issue but there is visible water ingress into the resistive touch screen.This is considered a known issue and is being addressed through an internal investigation.

Event Description

The customer reported while using the avea ventilator, delamination of the front panel in the bottom right hand corner.The customer reported this causes the front panel to be non-responsive when trying to select options on touch screen.There is no report of patient involvement associated with the event.

Manufacturer Narrative

The original information provided indicated an avea ventilator.The product involved is a vela ventilator.

Event Description

The customer reported while using the vela ventilator, delamination of the front panel in the bottom right hand corner.The customer reported this causes the front panel to be non-responsive when trying to select options on touch screen.There is no report of patient involvement associated with the event.

• 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: 5464955
• MDR Text Key: 39477171
• Report Number: 2021710-2016-03221
• 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: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: VELA COMP D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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