AVEA 17310-00Recalls & reported problems
Carefusion Corporation · AVEA, CMPRH, ENG, LNG, LO V, DISS, K · Class 2
Quick summary
This is a CareFusion AVEA ventilator, a machine used to help patients breathe in hospitals. The 71 reports mostly describe mechanical problems such as lost breathing volume, screen images that distort or go blank, constant circuit occlusion alarms, incorrect oxygen and pressure readings, leaks, and a missing compressor; most involved no patient. Seven reports involve injuries and there are no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10846446000047), received between Mar 29, 2019 and Apr 9, 2024 — classified as 7 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (43 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem43
- No Display/Image5
- Inaccurate Delivery4
- Display or Visual Feedback Problem3
- Erratic or Intermittent Display3
- Failure to Cycle2
- Appropriate Device Problem Term/Code Not Available1
- Display Difficult to Read1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Patient Involvement25
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- No Information3
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2024Display Difficult to Read; Display Difficult to Read
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR UIM (USER INTERFACE MODULE) IMAGE IS INTERMITTENTLY DISTORTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070832 ↗MalfunctionJan 4, 2024Tidal Volume Fluctuations; Tidal Volume Fluctuations
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR AFTER INSTALLING PM (PREVENTIVE MAINTENANCE) ON DEVICE, THE VTI (INHALED TIDAL VOLUME) IS HIGHER THAN SPECIFICATION AND THAT THE PEEP (POSITIVE END-EXPIRATORY PRESSURE) IS LOWER THAN SPECIFICATION. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18446040 ↗MalfunctionNov 27, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED TO VYAIRE MEDICAL THAT NO COMPRESSOR SCROLL OR WORKING COMPRESSOR 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 18209714 ↗MalfunctionNov 16, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS GIVING CONSTANT CIRCUIT OCCLUSION ALARM. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18154513 ↗MalfunctionNov 13, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT HIGH FRACTION OF INSPIRED OXYGEN 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 18124229 ↗MalfunctionNov 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT SMART CONNECTOR IS LEAKING FROM THE THREADED PORTION 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 18120126 ↗MalfunctionOct 18, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT LOW PEAK EXPIRATORY END PRESSURE 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 17962338 ↗InjurySep 12, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA DEVICE LOST VOLUME DURING USE ON A PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS REMOVED FROM THE DEVICE, BAGGED ( MANUAL RESUSCITATOR), AND THE AVEA WAS SWAPPED OUT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17731056 ↗MalfunctionJun 15, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS AN EXPIATORY TEMP ERROR ON THE BOTTOM OF THE SCREEN. FURTHERMORE, THERE IS NO INFORMATION ON PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17135250 ↗MalfunctionJun 14, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR INOPERABLE 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 17130797 ↗InjuryMay 8, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO (B)(6) MEDICAL, THAT THE AVEA VENTILATOR SHUT DOWN DURING TRANSPORT WHILE ON A PATIENT. FURTHERMORE, THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE WITH NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16887049 ↗MalfunctionApr 11, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR TOUCH SCREEN IS NOT WORKING AND WILL NOT CALIBRATE. 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 16718922 ↗MalfunctionApr 10, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT HIGH FRACTION OF INSPIRED OXYGEN 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 16710124 ↗MalfunctionDec 16, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS GETTING A VENT INOP (VENTILATOR INOPERABLE) ALARM. ERROR LOG SHOWS BAD XDCR CAL (TRANSDUCER CALIBRATION). 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 15998207 ↗MalfunctionOct 18, 2022Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR DISPLAY IS BLANK, UNIT TURNS ON BUT NO DISPLAY. FURTHERMORE, THERE IS NO PATIENT INVOLVEMENT WITH THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15629607 ↗MalfunctionMar 1, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR READING O2 (OXYGEN) SENSOR FAILURE. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636669 ↗MalfunctionDec 21, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VENTILATOR INOPERABLE 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 13056730 ↗MalfunctionOct 25, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR OCCURRED CIRCUIT OCCLUSION. 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 12694342 ↗MalfunctionOct 12, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR SHOWING EXTERNAL TEMPERATURE ERROR WHILE ON A 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 12616159 ↗MalfunctionSep 9, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS A FLOW SENSOR ISSUE. THE FLAP ON THE SENSOR IS STUCK AT THE END OF CROSS HAIRS . 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 12449061 ↗MalfunctionJun 11, 2021Volume Accuracy Problem; Volume Accuracy Problem
THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR EXPERIENCED HIGH INSPIRATORY TIDAL VOLUME (VTI) READING AFTER DOING PREVENTIVE MAINTENANCE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11986262 ↗MalfunctionMar 15, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR ALARMED TRANSDUCER FAULT AND CIRCUIT OCCLUSION ERROR. 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 11485773 ↗MalfunctionMar 10, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL AUTO-CYCLING, PEEP (POSITIVE END-EXPIRATORY PRESSURE) DISPLAYING 1 WHEN SET TO 6 ON 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 11454948 ↗MalfunctionFeb 24, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR EXPERIENCED UIM (USER INTERFACE MODULE) NOT RESPONDING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11375581 ↗MalfunctionFeb 18, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR ALARMED LOW MINUTE VENTILATION (VE) IN VOLUME GUARANTEE. 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 11343861 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.