AirLifeRecalls & reported problems across all models

We found 23 models of AirLife by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2019 and Nov 27, 2023 — classified as 15 injuries, 26 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. 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 AirLife problems

AirLife models

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

• AirLife 2D0737

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  6 reports
• AirLife 2K8004

  Cardiopulmonary Resuscitation Aid Kit
  4 reports
• AirLife 002620

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  3 reports
• AirLife CC10

  NEBULIZER (DIRECT PATIENT INTERFACE)
  3 reports
• AirLife 002002

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  2 reports
• AirLife 002502

  NEBULIZER (DIRECT PATIENT INTERFACE)
  2 reports
• AirLife 4681-504

  HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
  2 reports
• AirLife 3D0868

  NEBULIZER (DIRECT PATIENT INTERFACE)
  2 reports
• AirLife CK0010

  Humidifier nebulizer kit
  2 reports
• AirLife 5257

  NEBULIZER (DIRECT PATIENT INTERFACE)
  2 reports
• AirLife 002006

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  1 report
• AirLife 002433

  NEBULIZER (DIRECT PATIENT INTERFACE)
  1 report
• AirLife 2K8805

  Cardiopulmonary Resuscitation Aid Kit
  1 report
• AirLife 2K8038

  Cardiopulmonary Resuscitation Aid Kit
  1 report
• AirLife 2K8040

  Cardiopulmonary Resuscitation Aid Kit
  1 report
• AirLife 2K8085

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 report
• AirLife FN2438

  NEBULIZER (DIRECT PATIENT INTERFACE)
  1 report
• AirLife 2K7000

  Ventilator, Emergency, Manual (Resuscitator)
  1 report
• AirLife CK0005

  Humidifier nebulizer kit
  1 report
• AirLife 5504BGL1

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  1 report
• AirLife NIV041S

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  1 report
• AirLife AH102

  Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  1 report
• AirLife AH180

  Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  1 report

Recent AirLife adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2023Defective Component; Defective Component

  IT WAS REPORTED TO VYAIRE MEDICAL THAT PRIOR TO EXTUBATION, THE RESPIRATORY THERAPIST (RT) WAS SETTING UP OXYGEN TO MATCH WHAT WAS ON THE VENT. SHORTLY AFTER, A LOUD WHISTLE WAS HEARD FROM THE SAFETY PRESSURE VALVE. RT CHECKED EQUIPMENT AND NOTED THERE WAS NO HOLE ON 002006 - HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS LEADING TO THE CANNULA TO DELIVER OXYGEN. WHEN RT GRABBED A NEW ONE FROM THE RESPIRATORY CLOSET, HE NOTED IT HAD THE SAME DEFECT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212236 ↗
• MalfunctionAug 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002002 - NEBULIZER WITH AIR ENTRAINMENT WAS LEAKING FROM BOTTLE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443036 ↗
• MalfunctionJul 28, 2023Component Missing; Component Missing

  IT WAS REPORTED TO VYAIRE MEDICAL THAT ONE OF THE AH102 - CIRCUIT, ADULT, HEATED SINGLE LIMB WAS MISSING THE TIP OR THE ATTACHMENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419972 ↗
• MalfunctionMar 20, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE HUMIDIFIER KIT 500ML 12/CS ADAPTER DOES NOT FIT PROPERLY INTO THE FLOWMETER. DUE TO THIS, A LEAKAGE OCCURRED WHICH CAUSED A LOW OXYGEN SATURATION. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16573827 ↗
• MalfunctionFeb 6, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2433 - MM10 SVN W/ADULT MASK & 7FT TBG 50/CS DOESN'T WORK; IT DOESN'T MIST THE MEDICATION. THIS HAPPENED TWICE IN THE ICU (INTENSIVE CARE UNIT). THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306002 ↗
• MalfunctionOct 1, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BABY SAFE HYP INF, .5L, 60CMH20, MANO, NRPR DOES NOT PROVIDE ACCURATE PRESSURE. THE PRESSURE NEEDED TO BE INCREASED TO MAINTAIN THE FLOW TO THE BAG. 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 15523576 ↗
• InjuryAug 11, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ADULT HEATER DUAL LIMB CIRCUIT CAUSED A VENTILATOR'S HEATER TO ALARM WHILE CONNECTED TO A PATIENT. THE END-USER ATTEMPTED TO CONNECT THE CIRCUIT TO OTHER HEATERS, AND ALL EXPERIENCED THE SAME ALARM ISSUE. THE END-USER THEN REMOVED THE CIRCUIT FROM THE PATIENT AND REPLACED THE CIRCUIT WITH A NEW ONE, AND THE ISSUE WAS RESOLVED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214792 ↗
• MalfunctionAug 8, 2022Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002002 - NEBULIZER WITH AIR ENTRAINMENT DOES NOT HUMIDIFY THE AIR DESPITE BEING REPLACED AND SECURING THE CONNECTION. THE HUMIDIFIED AIR IS NEEDED FOR A PATIENT WITH TRACHEOSTOMY. THERE WERE NO REPORTS OF INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189074 ↗
• 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 ↗
• MalfunctionApr 14, 2022Fire; Fire

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 4681-504-INSPIRATORY LINE HTD 8FT ADULT 20/CS STARTED TO BURNED WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRM THAT THERE IS NO HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116193 ↗
• MalfunctionDec 17, 2021Fire; Fire

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 4681-504-INSPIRATORY LINE HTD 8FT ADULT 20/CS STARTED TO FIRE WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRM THAT THERE IS NO HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025437 ↗
• 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 ↗

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