MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA STANDARD VENTILATOR - INTERNAL COMPRESSOR; AVEA VENTILATOR

Catalog Number AVEA STD COMP

Device Problem Inaccurate Delivery (2339)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in.

Event Description

It was reported to vyaire medical that the fio2 was not reading correctly.Ran est and it failed due to a leak and no flow.Tried the exhalation characterization 3 times, on the 3rd try it passed.A pop was heard and he indicates after the pop there is no leak and there is flow.Consulted with the team via im.The pop was most likely due to a connection becoming loose.Unknown if patient was involved, asked but not answered.

• Brand Name: AVEA STANDARD VENTILATOR - INTERNAL COMPRESSOR
• Type of Device: AVEA VENTILATOR
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. 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: 18969294
• MDR Text Key: 338603232
• Report Number: 2021710-2024-18899
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 02/27/2024
• 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