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

Catalog Number AVEA STD COMP

Device Problem Inaccurate Delivery (2339)

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

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported to vyaire medical that the avea ventilator fio2 is dropping to 21% when set to 40% during patient use.No patient harm incurred during the reported event.

Manufacturer Narrative

Vyaire medical file indentification: (b)(4).The suspect device was not returned for evaluation therefore, a definitive root cause cound not be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information is received.

• Brand Name: AVEA STANDARD VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 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 ; 2402760001
• MDR Report Key: 18946058
• MDR Text Key: 338168500
• Report Number: 2021710-2024-18908
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10846446000641
• UDI-Public: (01)10846446000641(11)20120827
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AVEA STD COMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2012
• 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