AVEARecalls & reported problems across all models

We found 11 models of AVEA by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 296 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2018 and Jun 12, 2024 — classified as 2 deaths, 31 injuries, 263 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (180 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AVEA problems

AVEA models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AVEA 17312-00

  Ventilator, Continuous, Facility Use
  1 death84 reports
• AVEA 17310-00

  Ventilator, Continuous, Facility Use
  71 reports
• AVEA 17311-00

  Ventilator, Continuous, Facility Use
  1 death58 reports
• AVEA R17310-00

  Ventilator, Continuous, Facility Use
  36 reports
• AVEA R17210-00

  Ventilator, Continuous, Facility Use
  21 reports
• AVEA R17312-00

  Ventilator, Continuous, Facility Use
  16 reports
• AVEA 16465

  Ventilator, Continuous, Facility Use
  5 reports
• AVEA 3001042

  Ventilator, Continuous, Facility Use
  2 reports
• AVEA 50000-40033

  Ventilator, Continuous, Facility Use
  1 report
• AVEA 12283-PMN

  Ventilator, Continuous, Facility Use
  1 report
• AVEA 11790

  Ventilator, Continuous, Facility Use
  1 report

Recent AVEA adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 28, 2024No Device Output; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR IS NOT DETECTING THE CONNECTED HOT WIRE FLOW SENSOR ON THE FRONT PANEL. THE UNIT IS ON AN UNSTABLE NEONATE 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 18992966 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionJan 9, 2024Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT CIRCUIT DISCONNECT 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 18480980 ↗
• MalfunctionJan 5, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAS FIO2 (FRACTION OF INSPIRED OXYGEN) DRIFTING. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460867 ↗
• 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 ↗
• MalfunctionDec 20, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DROP IN PRESSURE ON NCPAP (NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE) MODE OCCURRED ON THE AVEA VENTILATOR.THEY HAVE THE VALUE SET AT 6 CMH20 BUT IT DROPS TO 2 CMH20. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369368 ↗
• MalfunctionDec 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAVING CIRCUIT OCCLUSION PROBLEMS EVEN WITH EST (EXTENDED SYSTEMS TEST) WHICH WAS ABLE TO PASS. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319830 ↗
• MalfunctionDec 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAVING CIRCUIT OCCLUSION PROBLEMS EVEN WITH EST (EXTENDED SYSTEMS TEST) WHICH WAS ABLE TO PASS. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318698 ↗

Other Carefusion Corporation products

• VELA5 models · 2,569 reports
• LTV 1200 VENTILATOR2 models · 362 reports
• Infant Flow SiPAP7 models · 109 reports
• LTV8 models · 97 reports
• 3100A HFOV7 models · 82 reports
• 3100B HFOV2 models · 64 reports
• AirLife23 models · 41 reports
• Blender6 models · 33 reports