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

Model Number AVEA

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

H3: 81-the suspect device was not returned for evaluation.However, vyaire's field service representative went on-site and noted when the avea ventilator was turned on, the ventilator alarmed high peak inspiratory pressure (ppeak).A definitive root cause could not be determined.

Event Description

Field service representative arrived on-site and turned on the avea ventilator.The ventilator then alarmed high ppeak.

• Brand Name: AVEA STANDARD VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18904496
• MDR Text Key: 337750334
• Report Number: 2021710-2024-18889
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10846446065169
• UDI-Public: (01)10846446065169
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AVEA
• Device Catalogue Number: AVEA STD N/COMP (2017)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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