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

Model Number AVEA COMP

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported replacing the power supply and the issue was resolved.The customer reported running the suspect device for several days straight and had no alarms or burning odors.The customer reported returning the suspect device to service.Any additional information received from the customer will be included in a follow-up report.(b)(4).The customer reported the suspect component is not available for analysis for carefusion.

Event Description

The customer reported loss of ac (alternating current) alarms while using the avea ventilator.The customer reported visual and audible alarms were present.The customer reported a burning smell was coming out of the suspect device.The issue occurred during patient use, and the customer reported the suspect device was removed from the patient.The customer reported there were no reports of patient harm associated with this event.The customer reported taking the vent out of service and troubleshooting.The customer reported opening up the power supply and found one of the capacitors has a bulge on top, and some oil is coming out of it.The customer reported the ventilator inlet fuses were fine and not burned and determined the alleged component is the power supply.The customer reported crosschecking the defect with a known good power supply, and the suspect device was working satisfactorily.

• 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: 5267853
• MDR Text Key: 32705940
• Report Number: 2021710-2015-02364
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVEA COMP
• Device Catalogue Number: 17210-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2006
• 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): Required Intervention