AVEA R17310-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10846446000016), received between Apr 22, 2019 and Jun 8, 2024 — classified as 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (22 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2024High Readings; High Readings

  IT WAS REPORTED TO VYAIRE MEDICAL, THE NEO VOLUME ON THE VENT IS READING 40ML VTI ON HIS CALIBRATED FLOW ANALYZER WHEN HE HOOKS UP AN ADULT LUNG AND 9.9ML WHEN USING A NEO LUNG. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493044 ↗
• MalfunctionApr 15, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED TO VYAIRE THAT THE AVEA UNIT IS FAILING TO PEEP VERIFICATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19108652 ↗
• MalfunctionJan 31, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT EXT HIGH PPEAK AND OCCLUSION ALARMS 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 18619756 ↗
• MalfunctionJul 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UIM (USER INTERFACE MODULE) SCREEN IS BLACK AFTER START UP. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391290 ↗
• MalfunctionMay 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CONNECTOR ON THE GDE (GAS DELIVERY ENGINE) OF THE AVEA VENTILATOR WAS NOT PICKING UP THE UIM (USER INTERFACE MODULE). THERE WAS NO PATIENT INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001069 ↗
• MalfunctionApr 19, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS INACCURATE PEEP (POSITIVE END EXPIRATORY PRESSURE). 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 16770552 ↗
• MalfunctionApr 11, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT SCREEN IS NOT WORKING PROPERLY 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 16718919 ↗
• MalfunctionFeb 3, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS SET FOR FIO2 (FRACTION OF INSPIRED OXYGEN) OF 40, THE VENTILATOR IS READING 47. THE UNIT IS GETTING A HIGH FIO2 (FRACTION OF INSPIRED OXYGEN) ALARM AND THE ANALYZER IS READING 39. 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 16294023 ↗
• MalfunctionDec 22, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CUSTOMER IS UNABLE TO GET ACCURATE FIO2 (FRACTION OF INSPIRED OXYGEN) WITH MULTIPLE ATTEMPTS ON A AVEA VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036118 ↗
• MalfunctionAug 26, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR TOUCH SCREEN WAS UNRESPONSIVE DURING ROUTINE USE. THE UNIT WAS USED IN A CLASSROOM SETTING. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15305131 ↗
• InjuryAug 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UIM (USER INTERFACE MODULE) ON THE UNIT HAD AN ISSUE WHERE THE GRAPHICS ON THE DISPLAY BECAME UNREADABLE (BLURRY/PIXELATED) WHILE ON A PATIENT. THE UNIT WAS SWAPPED TO A DIFFERENT UNIT. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280381 ↗
• MalfunctionJul 11, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAD HIGH FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978739 ↗
• MalfunctionJun 24, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR FRACTION OF INSPIRED OXYGEN (FIO2) READINGS ARE A LITTLE TOO HIGH. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808257 ↗
• InjuryApr 15, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED FRACTION OF INSPIRED OXYGEN IS OUT OF RANGE AT 35 PERCENT DURING USE ON A PATIENT ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THE DEVICE WAS TAKEN OFF AND ANOTHER VENTILATOR WAS PLACED ON THE PATIENT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14123462 ↗
• MalfunctionMar 11, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED NO DISPLAY - USER INTERFACE MODULE ISSUE 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 13739405 ↗
• MalfunctionFeb 15, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR WAS HAVING AN FIO2 (FRACTION OF INSPIRED OXYGEN) ISSUE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536332 ↗
• MalfunctionFeb 3, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR ALARMED CIRCUIT OCCLUSION, CIRCUIT DISCONNECT AND HIGH FIO2 (FRACTION OF INSPIRED OXYGEN) WHILE ON A PATIENT. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443926 ↗
• MalfunctionJan 26, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UNIT ALARMED HIGH FIO2 (FRACTION OF INSPIRED OXYGEN). THE CUSTOMER STATED THAT HE DID NOT SEE THAT SPECIFIC ERROR IN THE ERROR LOG BUT DID NOTICE THE INACCURACY OF THE FIO2 AND STATED THAT THE O2 WAS OUT OF RANGE AT 30 AND 50% AND THAT THE O2 SENSE CABLE WAS DAMAGED. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358888 ↗
• MalfunctionOct 29, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED DATA CONFIGURATION LOST AND VENTILATOR INOPERABLE STATE 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 12720617 ↗
• MalfunctionOct 7, 2021Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  THE CUSTOMER REPORTED THE DISPLAY GOING OUT AFTER A FEW MINUTES FROM POWER UP 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 12591363 ↗
• MalfunctionSep 23, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR EXPERIENCED DISPLAY ON UNIT GOING BLANK WHEN UNIT IS ON. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523495 ↗
• InjuryJul 7, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED NOT ADEQUATE TIDAL VOLUMES ON A PATIENT ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THE PATIENT WAS MOVED TO ANOTHER 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 12129822 ↗
• MalfunctionJun 23, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED FRACTION OF INSPIRED OXYGEN READING ARE ERRATIC AND SOMETIMES NOT READING AT ALL 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 12054137 ↗
• MalfunctionJun 17, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED CIRCUIT OCCLUSION, CIRCUIT DISCONNECT, HIGH FRACTION OF INSPIRED OXYGEN AND FRACTION OF INSPIRED OXYGEN IS OUT OF TOLERANCE 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 12018371 ↗
• MalfunctionApr 20, 2021Mechanical Problem; Mechanical Problem

  IT IS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR EXPERIENCED CIRCUIT OCCLUSION AND CIRCUIT DISCONNECT WHILE ON A PATIENT. THERE WAS NO INFORMATION REGARDING PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694624 ↗