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

Model Number AVEA

Device Problems Nonstandard Device (1420); Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification: (b)(4).Any additional information is received it will be included in a follow-up report.(b)(4).Field service rep evaluation: 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 an unresolved circuit occlusion alarm on this avea ventilator.The customer stated this issue was not associated with a patient event.

• 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: 6364896
• MDR Text Key: 68974631
• Report Number: 2021710-2017-05488
• 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: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/28/2017

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: AVEA
• Device Catalogue Number: 17311-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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