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

Model Number VELA

Device Problem Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

The following reported event originated from a foreign distributor in (b)(6).The distributor reported a touch screen that is unresponsive.No signs of damage by the end user.The touch screen argon gas escaped(delaminating).No patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

Failure analysis lab received a front panel assembly, vela diamond w/co2.The front panel assembly was installed in known good u.The unit was powered up unit and failure analysis could not duplicate ¿screen non-responsive¿.The front panel screen functions correctly.Fluid ingress was noted.This reported event considered a known issue addressed with an internal action.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE/ CBK
• Manufacturer (Section D): CAREFUSION ; yorba linda CA
• Manufacturer (Section G): CAREFUSION ; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jacquiline tamal ; 7607787234
• MDR Report Key: 4746409
• MDR Text Key: 5706548
• Report Number: 2021710-2015-00868
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 04/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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