MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number AVEA

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Information (3190)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.Therefore, no root cause can be determined yet.

Event Description

The customer reported the volumes in ped mode fluctuate and are inconsistent issues on the avea ventilator.There is no information regarding patient involvement that was associated with the reported event.

• Brand Name: AVEA VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs, ca
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10135961
• MDR Text Key: 194647098
• Report Number: 2021710-2020-12022
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10846446066074
• UDI-Public: (01)10846446066074(11)20181201
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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: 32029-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2018
• 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