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

Model Number AVEA STD

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information received from customer will be included in a follow up report.(b)(4).Results of investigation: a carefusion field service representative went onsite to evaluate the suspect device.This reported issue has been identified to be related to a known issue being addressed through a field corrective action.Remediation and repair of the suspect device has been completed and no further investigation is required.

Event Description

The customer reported while using the avea ventilator, it is alarming circuit occlusion and ext high ppeak pressures.The customer reported the unit was on a patient when the reported issue occurred but there was no patient harm or injury.

• Brand Name: AVEA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6216510
• MDR Text Key: 63669751
• Report Number: 2021710-2016-05157
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVEA STD
• Device Catalogue Number: 17212-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1609-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention