AVEA R17312-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10846446000351), received between Mar 9, 2020 and Jul 7, 2022 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED DEVICE GIVES INTERMITTENT LOSS OF AIR ALARM 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 14951776 ↗
• MalfunctionMar 30, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE THAT THE AVEA VENTILATOR, WAS SET THE FIO2 (FRACTION OF INSPIRED OXYGEN) AT 90 BUT THE READING IS 98%. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590202 ↗
• MalfunctionSep 16, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE COMPRESSOR OF THE AVEA VENTILATOR IS NOT TURNING ON. 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 10543954 ↗
• MalfunctionApr 29, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED AFTER RUNNING FOR A WHILE THE USER INTERFACE MODULE GOES BLANK ON THE AVEA VENTILATOR. THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT THAT WAS ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10012430 ↗
• MalfunctionApr 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR HAS NO O2 FLOW AND FIO2 INACCURACY. THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 10012370 ↗
• MalfunctionApr 28, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA UNIT DISPLAY IS NOT WORKING. THERE IS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10007732 ↗
• MalfunctionApr 24, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA UNIT GIVING VENT INOP DURING TESTING THE TECHNICIAN TURNED THE VENT ON AND 15 MINUTES LATER, VENT INOP THEN BURNING SMELL. THERE IS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9998851 ↗
• MalfunctionApr 24, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR IS ALARMING O2 CELL ERROR. A MESSAGE APPEARS STATING THAT O2 CONCENTRATION IS LOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9998812 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THEIR AVEA VENTILATOR HAD FIO2 ISSUE. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME.

  Patient problems: No Information

  MAUDE report 9986798 ↗
• MalfunctionApr 21, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED DEVICE IS ALARMING VENT INOP AND HIGH PMAX ISSUE ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT THAT WAS ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9983093 ↗
• MalfunctionApr 9, 2020Volume Accuracy Problem; Volume Accuracy Problem

  THE CUSTOMER REPORTED THE TIDAL VOLUME OF THE AVEA VENTILATOR IS LOW. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME.

  Patient problems: No Information

  MAUDE report 9946289 ↗
• MalfunctionApr 6, 2020No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL REPORTED THAT THE AVEA VENTILATOR ON START UP THE UIM TOUCH SCREEN STAYS BLANK AND IT DOES BOOT UP. THERE IS NO PATIENT INVOLVEMENT ON THE ASSOCIATED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9931815 ↗
• MalfunctionApr 6, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR HAS NO DISPLAY DURING START UP. THE UIM TOUCHSCREEN STAYS BLACK AND THE UNIT DOES NOT BOOT UP. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9931793 ↗
• MalfunctionApr 4, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THEIR AVEA VENTILATOR UIM TOUCH SCREEN STAYS DARK WHEN VENT IS TURNED ON. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9926113 ↗
• MalfunctionMar 23, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THEY HEARD SOMETHING POP ON THE AVEA STD COMP DEVICE AND THE DEVICE BLACKS OUT WHILE BEING USED ON A PATIENT. THE CUSTOMER SWITCHED OFF AND ON THE UNIT BUT IT IS NOT POWERING ON. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT HARM IN THIS REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9870586 ↗
• InjuryMar 9, 2020Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER REPORTED THAT THE AVEA SHOWED 87% LEAK DURING VENTILATION ON A PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND THEY REPLACED ANOTHER DEVICE. AT THIS TIME, PATIENT HARM IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806888 ↗