AVEA 17312-00 (UDI 10846446000368)Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10846446000368), received between Dec 7, 2018 and Mar 28, 2024 — classified as 1 death, 8 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (50 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024No Device Output; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS NOT DETECTING THE CONNECTED HOT WIRE FLOW SENSOR ON THE FRONT PANEL. THE UNIT IS ON AN UNSTABLE NEONATE PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992966 ↗
• MalfunctionJan 9, 2024Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT CIRCUIT DISCONNECT ALARM OCCURRED ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480980 ↗
• MalfunctionJan 5, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS FIO2 (FRACTION OF INSPIRED OXYGEN) DRIFTING. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460867 ↗
• MalfunctionDec 20, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DROP IN PRESSURE ON NCPAP (NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE) MODE OCCURRED ON THE AVEA VENTILATOR.THEY HAVE THE VALUE SET AT 6 CMH20 BUT IT DROPS TO 2 CMH20. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369368 ↗
• MalfunctionDec 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAVING CIRCUIT OCCLUSION PROBLEMS EVEN WITH EST (EXTENDED SYSTEMS TEST) WHICH WAS ABLE TO PASS. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319830 ↗
• MalfunctionDec 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAVING CIRCUIT OCCLUSION PROBLEMS EVEN WITH EST (EXTENDED SYSTEMS TEST) WHICH WAS ABLE TO PASS. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318698 ↗
• MalfunctionNov 7, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAD A DEVICE ERROR MESSAGE (MULTIPLE ERRORS FOR EX TEMP SENSOR) AFTER SETUP PRIOR PATIENT USE. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085596 ↗
• MalfunctionAug 29, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A LOW PEEP (POSITIVE END-EXPIRATORY PRESSURE) ALARM HAS OCCURRED ON THE AVEA VENTILATOR. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643719 ↗
• MalfunctionAug 18, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS LOW VOLUMES ON DELIVERY COMPARED TO THE MONITOR. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574243 ↗
• MalfunctionAug 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR LED ON THE POWER SUPPLY IS BLINKING WHEN AC POWER IS PRESENT AND DURING THE BATTERY TEST THE VENT TURNS OFF AND ON CONSTANTLY. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561693 ↗
• MalfunctionAug 13, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAD A FRACTION OF INSPIRED OXYGEN (FIO2) INACCURACY. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538061 ↗
• MalfunctionJul 9, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR SCREEN WENT BLACK WHILE ON PATIENT. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17284080 ↗
• MalfunctionJun 29, 2023Erratic or Intermittent Display; Mechanical Problem; Erratic or Intermittent Display; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SCREEN OF THE AVEA VENTILATOR WAS FLICKERING BLACK AND WHITE AFTER REPLACING THE UIM (USER INTERFACE MODULE). THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233117 ↗
• InjuryJun 15, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR'S UIM WENT WHITE DURING PATIENT USE. THE UNIT WAS SWAPPED OUT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135240 ↗
• MalfunctionMay 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE FAN WAS NOT RUNNING IN AFTER REPLACING THE POWER SUPPLY IN THE AVEA VENTILATOR. THEY ALSO BEGAN TO SMELL BURNING AND FOUND THAT THE CONNECTION BETWEEN THE COMPRESSOR AND THE PCB (PRINTED CIRCUIT BOARD) WAS BURNT. THERE WAS NO PATIENT INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936745 ↗
• MalfunctionFeb 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS A LEAK ON THE AVEA VENTILATOR. IT WAS ALSO STATED THAT A VENT INOP HAS OCCURRED. THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390481 ↗
• MalfunctionNov 22, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DEVICE IS AUTO-CYCLING ONLY WHEN THE WYE FLOW SENSOR IS HOOKED UP TO THE VENTILATOR ON THE AVEA DEVICE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847778 ↗
• MalfunctionSep 14, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR INOPERABLE ALARM OCCURRED ON THE AVEA VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421192 ↗
• MalfunctionMar 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS READING NEGATIVE PRESSURES ON THE SCREEN DURING VENTILATION AND STARTS TO AUTO CYCLE RANDOMLY AFTER AWHILE. AS OF THIS TIME THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956549 ↗
• MalfunctionMar 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS LEAK. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866587 ↗
• MalfunctionFeb 9, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS 100% LEAK AND THE SOME OF THE MONITORED VALUES HAVE ASTERISKS. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498746 ↗
• MalfunctionDec 14, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THE DEVICE WAS AUTO-CYCLING ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003335 ↗
• MalfunctionDec 14, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR WAS AUTO-CYCLING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003244 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS FIO2 (FRACTION OF INSPIRED OXYGEN) BLENDER ISSUE. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849155 ↗
• MalfunctionOct 1, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR ALARMED EXTENDED HIGH PEAK PRESSURE AND CIRCUIT OCCLUSION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565180 ↗