MAUDE Adverse Event Report: VYAIRE MEDICAL, 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 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported calibrating the transducers however, that did not resolve the reported event.The customer reported the suspect device component is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect device component for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported during pre-use on startup, this ventilator device displayed a circuit occlusion alarm.The customer reported that there was no patient involvement.

Manufacturer Narrative

Results of investigation: the vyaire failure analysis laboratory received the suspect flow control valve (fcv) for investigation.The physical inspection found no anomalies with the fcv.The investigation did not duplicate the customer event during the performance and manufacture testing, which the fcv passed.Therefore, a definite root cause can not be determined, since no fcv component failure was identified.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): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7182701
• MDR Text Key: 97066808
• Report Number: 2021710-2018-07287
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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: 17211-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• 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