AVEA R17210-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10846446000023), received between May 9, 2019 and Jun 12, 2024 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR SCREEN IS WHITE. NO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524999 ↗
• MalfunctionMay 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS BEEN SITTING FOR A PERIOD OF TIME AND THAT IT IS NOT CURRENTLY FUNCTIONAL. IT DOES NOT VENTILATE AT ALL, NO WAVEFORMS, UNIT WOULD NOT PERFORM EST (EXTENDED SYSTEMS TEST), ALARMING CIRCUIT DISCONNECT/OCCLUSION. 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 16903335 ↗
• InjuryAug 5, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR VOLUMES WERE INCORRECT. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REMOVED FROM THE 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 15178876 ↗
• MalfunctionAug 4, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR ALARMED LOW FIO2 WHILE CONNECTED TO A PATIENT. THE CUTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170723 ↗
• MalfunctionJul 25, 2022Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099311 ↗
• MalfunctionMay 18, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR WAS EXPERIENCING A POSITIVE END-EXPIRATORY PRESSURE (PEEP) INSTABILITY AND REQUESTED A PEEP CALIBRATION CODE. THE EVENT HAPPENED DURING SET UP PRIOR PATIENT USE. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428918 ↗
• MalfunctionApr 11, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS AUTO CYCLING. 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 14079352 ↗
• MalfunctionFeb 18, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UNIT IS CONSTANTLY AUTO CYCLING AND THE PEEP +3. 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 13562146 ↗
• MalfunctionDec 15, 2021Mechanical Problem; Mechanical Problem

  IT IS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR EXPERIENCED THE O2 WAS NOT READING CORRECTLY, TO RESOLVE THE ISSUE THE TECH CHANGED THE CABLE AND RESULTED TO VENT INOP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012171 ↗
• MalfunctionMay 24, 2021Mechanical Problem; Mechanical Problem

  A CUSTOMER CONTACTED VYAIRE MEDICAL TO REPORT THAT THEY ENCOUNTERED A HIGH FIO2 AND LOW FIO2 ALARMS CONTINUOUSLY ON THE AVEA VENTLATOR. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR HARM.

  Patient problems: Insufficient Information

  MAUDE report 11873803 ↗
• MalfunctionMar 9, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED DEVICE IS GIVING MUTI-ERROR CODES AND IS INOPERABLE ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. 6. TESTS/LAB DATA, INCLUDING DATES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446438 ↗
• MalfunctionFeb 23, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR EXPERIENCED INACCURATE DELIVERY READINGS. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368416 ↗
• MalfunctionFeb 18, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR EXPERIENCED LOW DELIVERED FIO2 (FRACTION OF INSPIRED OXYGEN). THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343916 ↗
• MalfunctionFeb 17, 2021Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR OCCURRED BLANK SCREEN. AT THIS TIME, PATIENT INVOLVEMENT IS UNKNOWN WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337898 ↗
• MalfunctionFeb 15, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS AN AUTO CYCLING ISSUE AND DISPLAY MULTIPLE ALARMS CIRCUIT DISCONNECT, LOW VE (LOW MINUTE VENTILATION), LOW PEEP (POSITIVE END-EXPIRATORY PRESSURE), LOW PIP (PEAK INSPIRATORY PRESSURE). 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 11327768 ↗
• MalfunctionJan 19, 2021Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED TO VYAIRE THAT AVEA HAS BAD OXYGEN CELL, DEAD BATTERY, AIRWAY LEAKAGE AND FAILED INSPIRATION TRANSDUCER CALIBRATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197830 ↗
• MalfunctionDec 30, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE DEVICE EXPERIENCED AVEA VENTILATOR'S O2 VALVE/MOTOR APPEARS TO STICK INTERMITTENTLY THAT ONLY DELIVERS 21% O2 REGARDLESS OF THE SETTING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11093638 ↗
• MalfunctionNov 9, 2020Erratic or Intermittent Display; Erratic or Intermittent Display

  THE CUSTOMER REPORTED THAT THE USER INTERFACE MODULE IS INTERMITTENTLY POWERING UP ON AVEA VENTILATOR. AT THIS TIME, PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10813640 ↗
• InjuryMay 15, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR WENT INOP. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063106 ↗
• MalfunctionApr 17, 2020Display Difficult to Read; Display Difficult to Read

  THE CUSTOMER REPORTED THAT THE AVEA HAS AN OPEN CRACKS AROUND PERIMETER. THE DISPLAY IS VERY DIM IT IS ALMOST UNREADABLE. THERE IS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9973050 ↗
• MalfunctionMay 9, 2019Failure to Cycle; Failure to Cycle

  IT WAS REPORTED TO VYAIRE AN AVEA VENTILATOR WENT INTO AN INOPERATIVE CONDITION WHILE IN PATIENT USE. THE PATIENT WAS MOVED TO A BACK-UP VENTILATOR. THE CUSTOMER ADVISED THERE WAS NO PATIENT HARM WAS ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED SPORADIC INVALID CONFIG AND TEMP ERRORS IN THE ERROR LOG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8596047 ↗