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

Model Number VELA COMP D

Device Problem Delamination (2904)

Patient Problem No Information (3190)

Event Date 03/31/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.The customer did not advise if the incident occurred on a patient.Customer advocacy has requested this information but has yet to receive and answer.At this time, carefusion has not received the device from the customer.(b)(4).

Event Description

The customer stated that the touch screen is delaminating and is inactive to the touch.The customer has not provided any information if this incident occurred on a patient.Customer advocacy has requested this information however has yet to receive a response.

• 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 ; 7149229830
• MDR Report Key: 5313754
• MDR Text Key: 34693873
• Report Number: 2021710-2015-02526
• 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: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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