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AirLife 2D0737Recalls & reported problems

Carefusion Corporation · Airlife™ Sterile water for Inhalation, USP 2000 ml · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403026607), received between Jul 13, 2021 and Aug 2, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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

Device problems

  • Contamination /Decontamination Problem6

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Fever1
  • Tachycardia1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THERE WAS A RUST-COLORED OR DARK-RED SUBSTANCE ATTACHED TO THE TO THE HUMIDIFICATION CHAMBER'S INNER PLASTIC AND FLOATING INSIDE THE WATER OF THE HUMIDIFICATION CHAMBER WHILE ON A PATIENT. NO HARM IS ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15154086 ↗
  • MalfunctionAug 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THERE WAS A RUST-COLORED OR DARK-RED SUBSTANCE ATTACHED TO THE TO THE HUMIDIFICATION CHAMBER'S INNER PLASTIC AND FLOATING INSIDE THE WATER OF THE HUMIDIFICATION CHAMBER WHILE ON A PATIENT. NO HARM IS ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15154085 ↗
  • MalfunctionMay 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

    THE CUSTOMER REPORTED THAT THE WATER STERILE F/INHALATION 2000ML 6/CS EXPERIENCED DEPOSITS IN THE CHAMBER DURING USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14459601 ↗
  • MalfunctionMay 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

    THE CUSTOMER REPORTED THAT THE WATER STERILE F/INHALATION 2000ML 6/CS EXPERIENCED DEPOSITS IN THE CHAMBER DURING USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14459425 ↗
  • MalfunctionOct 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

    THE CUSTOMER REPORTED THAT THE WATER STERILE F/INHALATION 2000ML 6/CS EXPERIENCED DEPOSITS IN THE CHAMBER DURING USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12661884 ↗
  • InjuryJul 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

    THE CUSTOMER REPORTED THAT THE WATER STERILE F/INHALATION 2000ML 6/CS EXPERIENCED TO HAVE A WHITE RESIDUE AND CAUSED THEIR SON TO HAVE A TEMPERATURE AND INCREASED HEART RATE.

    Patient problems: Fever; Tachycardia

    MAUDE report 12163901 ↗

Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices

All HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.