AVEA 17311-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10846446000672), received between Apr 19, 2019 and May 15, 2024 — classified as 1 death, 6 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (35 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Low Readings; Low Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THE CUSTOMER IS REQUESTING ONSITE SERVICE FOR LOW PEEP. THE REPORTED ISSUE OCCURRED WHILE IN PATIENT USE. THERE WAS NO PATIENT HARM SINCE THE AVEA VENTILATOR WAS SWAPPED WITH ANOTHER VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323172 ↗
• MalfunctionMar 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR SHOWED LOW POSITIVE END-EXPIRATORY PRESSURE (PEEP), MOISTURE, AND ASKED FOR AVEA PM CODES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827747 ↗
• MalfunctionJan 22, 2024Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UNIT WILL LOSE AC POWER AT RANDOM TIMES OR MAY NOT START ON AC WHILE ON A PATIENT. THE INTERNAL BATTERIES ARE BEING DEPLETED SINCE THE ISSUE IS RANDOM. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553224 ↗
• MalfunctionNov 1, 2023Mechanical Problem; Device Emits Odor; No Device Output; Mechanical Problem; Device Emits Odor; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS GIVING VENT INOP ALARM AND HAS A BURNING SMELL. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048433 ↗
• MalfunctionJun 29, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VYAIRE MEDICAL THAT IMPROPER POWER DOWN ON ERROR LOG 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 17232787 ↗
• InjuryApr 18, 2023Reset Problem; Reset Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR TURNS OFF RANDOMLY WHILE UNIT WAS ON A PATIENT. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED. THE UNIT WAS SWAPPED WITH ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763983 ↗
• DeathSep 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT HAD DIED WHILE ON AN AVEA VENTILATOR. NO OTHER DETAILS WERE PROVIDED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15419406 ↗
• MalfunctionJul 18, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR HAS A DEFECTIVE GDE (GAS DELIVERY ENGINE). THERE IS NO INFORMATION ON PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048662 ↗
• MalfunctionJul 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR CONSTANTLY SHOWING 0.8 FOR CIRCUIT COMPLIANCE AND IS SHOWING MONITORED VTE (END TIDAL VOLUME) AT 0.84 WHERE THE ANALYZER READINGS AND VTI (INHALED TIDAL VOLUME) ARE GOOD. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033606 ↗
• MalfunctionJul 15, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS A DEFECTIVE GDE (GAS DELIVERY ENGINE). FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15031113 ↗
• MalfunctionJun 24, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR WAS HAVING A HIGH FRACTION OF INSPIRED OXYGEN (FIO2) ALARM. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808265 ↗
• MalfunctionJun 15, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED UNIT NOT HOLDING SETTINGS OR TIME 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 14708812 ↗
• MalfunctionApr 11, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS AUTO CYCLING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE ISSUE OCCURRED DURING SET-UP, PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079566 ↗
• MalfunctionFeb 9, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UNIT CONTINUOUSLY AUTO CYCLING. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502246 ↗
• MalfunctionJan 3, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THE DEVICE FAILED ON A PATIENT AFTER OXYGEN SENSOR CHANGED ON THE AVEA VENTILATOR. AT THIS TIME,, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13144403 ↗
• MalfunctionDec 15, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS HAVING A LOW FIO2 (FRACTION OF INSPIRED OXYGEN) ALARM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012222 ↗
• MalfunctionDec 6, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR DISPLAY IS BLACK UPON POWER UP. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12942407 ↗
• MalfunctionDec 3, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS WHITE SCREEN ON POWER UP. 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 12929179 ↗
• MalfunctionNov 23, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR EXPERIENCED LOW FIO2 ALARM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865510 ↗
• MalfunctionNov 11, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR AFTER INSTALLING GDE (GAS DELIVERY ENGINE) WENT INOP (INOPERABLE). ERROR IN THE EVENT LOG NOTED PNEUMATICS FTC (FAILURE TO CYCLE) AND LENDER DATA ERROR. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800717 ↗
• MalfunctionOct 1, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UNIT HAS BLACK DISPLAY ISSUE. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562788 ↗
• MalfunctionSep 13, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UNIT PRESENTED WITH MULTIPLE ERROR CODES EXP TEMP ERROR, CONFIG LOSS, SETTINGS LOSS, AND INVALID CONFIG ON COMPRESSOR. 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 12460781 ↗
• MalfunctionJun 21, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR EXPERIENCED TOUCH SCREEN FREEZES AND SHUTS DOWN UNIT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ISSUE WAS DETECTED DURING SETUP PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036057 ↗
• MalfunctionJun 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS BROKEN OR UNIT IS HAVING "IMPROPER POWER DOWN". 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 11932749 ↗
• MalfunctionMay 11, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  A CUSTOMER CONTACTED VYAIRE MEDICAL TO REPORT THAT THE AVEA UNIT HAD A HIGH FIO2 ALARM. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806816 ↗