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

Model Number AVEA

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

The customer has not requested a return good authorization (rga) for an analysis of the device/component.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 a ventilator inoperative condition while in patient use and multiple display alarm conditions.The customer reported no patient harm was associated with this event.

• 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: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7557165
• MDR Text Key: 109663188
• Report Number: 2021710-2018-07920
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: KE
• PMA/PMN Number: K103211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVEA
• Device Catalogue Number: 17610-09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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): Required Intervention