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AVEA 16465Recalls & reported problems

Carefusion Corporation · HOTWIRE FLOW, SENSOR, NEONATAL · Class 2

All models of AVEA (11)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846446001198), received between Mar 25, 2019 and Apr 19, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Mechanical Problem3
  • Failure to Sense1
  • Human-Device Interface Problem1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 19, 2023Leak/Splash; Leak/Splash

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR SHOWS HIGH LEAK PERCENTAGE IF HOT WIRE SENSOR IS CONNECTED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16770676 ↗
  • MalfunctionJan 30, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA HOTWIRE FLOW, SENSOR, NEONATAL WHILE ON A PATIENT, WHEN A PROXIMAL FLOW SENSOR WAS IN USE WITH A NEONATAL CIRCUIT THE MEASURED VOLUMES WERE READING MUCH LOWER THAN EXPECTED. 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 16265030 ↗
  • MalfunctionOct 3, 2022Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HOTWIRE FLOW SENSOR IS NOT MEASURING TIDAL VOLUME. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15534120 ↗
  • MalfunctionDec 29, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE HOTWIRE FLOW,SENSOR,NEONATAL ONE OR TWO OF THE HOT WIRE FLOW SENSOR THAT ONE OF HER CUSTOMER IS USING IS NOT WORKING PROPERLY. THERE ARE 2 FLOW SENSORS. ONE IS AUTO CYCLING, AND THE OTHER IS "NOT RECOGNIZED" BY THE ACTUAL VENTILATOR. 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 13114923 ↗
  • InjuryMar 25, 2019Failure to Sense; Human-Device Interface Problem; Failure to Sense; Human-Device Interface Problem

    THE CUSTOMER REPORTED A NEONATAL HOTWIRE FLOW SENSOR STOPPED INTERFACING WITH ONE OF THEIR VENTILATOR DEVICE, WHILE IN PATIENT USE. THE CUSTOMER STATED NO PATIENT IMPACT WITH THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8447938 ↗

Other Ventilator, Continuous, Facility Use devices

All Ventilator, Continuous, Facility Use devices →

Sources and updates

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