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

Model Number AVEA STD

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer stated he was able to identify the issue and determined that the user interface module cable needed to be replaced.Due to the issue being resolved the unit will not be returned for evaluation.In the event additional information becomes available a follow-up report will be submitted.(b)(4).

Event Description

The customer stated that during use after about an hour the touchscreen display picture becomes distorted.There were no patient issues or harm reported.The biomed was able to duplicate the issue after about an hour of use in the default adult settings.The customer called back at a later date and stated that they were able to identify the issue and replaced the user interface module cable and the issue was resolved therefore the unit would not be returned to the factory.

• Brand Name: AVEA 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: 5355867
• MDR Text Key: 35491149
• Report Number: 2021710-2016-02651
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 17311-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2008
• 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
• Patient Outcome(s): Other