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 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the vyaire failure analysis laboratory has received the suspect gas delivery engine (gde) but it is still under investigation.The completed investigation will be included in a follow-up report.

Event Description

The customer reported an unresolved extended high peak and circuit occlusion alarm, on this ventilator device.The customer reported that there was no patient involvement.

Manufacturer Narrative

The vyaire failure analysis laboratory received the suspect transducer communication alarm (tca) assembly for investigation.The physical inspection found no anomalies with the tca.The investigation did not duplicate the customer event during the performance and manufacture testing.The alarm conditions and device behavior were not present during the component testing of the transducer communication alarm (tca) assembly.A component cause of this failure was not determined during the investigation therfore, no component root cause could be determined.The tca assembly will be held for trending and internally investigated within vyaire.

• 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: 7314769
• MDR Text Key: 101566589
• Report Number: 2021710-2018-07479
• 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: 03/05/2018

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1