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

Model Number AVEA

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

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.(b)(4).The customer reported the suspect component is available for analysis and a facility service evaluation of the device has been scheduled.At this time, carefusion has not completed the evaluation, which will be included in a follow-up report.

Event Description

The customer reported during pre-use on startup after passing the extended systems test (est), this avea ventilator displayed a circuit occlusion alarm and no flow output was observed.The customer reported that there was no patient involvement.

Manufacturer Narrative

The vyaire failure analysis laboratory received the suspect gas delivery engine (gde) for investigation.The physical inspection found no anomalies with the gde.The investigation did duplicate the customer event during the performance and manufacture testing.The alarm conditions and device behavior has been identified with a railed expiratory pressure transducer component on the transducer communication alarm (tca) assembly within the gde.The root cause is associated with a material issue of the expiratory pressure transducer.Vyaire will track and trend this reported issue and internally investigate the situation.

• 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: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6586274
• MDR Text Key: 75855958
• Report Number: 2021710-2017-05997
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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: 17310-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 09/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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