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

Model Number AVEA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information received from customer will be included in a follow up report.At this time, carefusion has not received the suspect device/component for evaluation.The user facility is conducting further investigations to the possible sources of the infections.There is no further information provided at this time and no return of products are expected.(b)(4).

Event Description

The customer reported a general concern across their hospital that ventilators were potentially causing infections in patients.The customer reported that it was not only with carefusion ventilators but also ventilators from other manufacturers.The customer has been checking possible systemic sources of infection, such as suctioning channels, hvac, and non hygienic practices, but has not found a source yet.The customer's infection control department is suspecting the ventilators as well as other sources.There was no information or details on the infections or conditions of the patients and at this time there is no known issue directly related to the performance of the ventilators.

• 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: 6201440
• MDR Text Key: 63174843
• Report Number: 2021710-2016-05084
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: K103211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AVEA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening