Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve 002006Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Bubble Humidifier With 6 psi Pressure Relief Valve · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10190752114791), received between May 3, 2021 and Jan 2, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Device Handling Problem1
- Obstruction of Flow1
Patient problems
- Low Oxygen Saturation2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2024Device Handling Problem; Device Handling Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002006 HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS WAS INCORRECTLY CONNECTED TO THE HEATER OF A 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 18428419 ↗InjuryDec 19, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED TO VYAIRE MEDICAL THAT AFTER ATTEMPTING TO PLACE A PATIENT ON AN INTERMEDIATE FLOW NASAL CANNULA (12 LPM).THE PATIENT DESATURATED TO 77% SPO2. IT WAS DISCOVERED THAT THE 002006 HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS HAD NO HOLE PRESENT ON THE 02 FLOW OUTLET. THE RESPIRATORY THERAPIST THEN PLACED THE PATIENT ON HFNC (HIGH FLOW NASAL CANNULA) AT 50% 02. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: Low Oxygen Saturation
MAUDE report 18360566 ↗InjuryMay 3, 2021Defective Device; Defective Device
THE CUSTOMER REPORTED THAT THE AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE EXPERIENCED FLOW ISSUE THAT RESULTED TO PATIENT DESATURATION. AS AN INTERVENTION, BOTH CANNULA AND BOTTLE WERE CHANGED.
Patient problems: Low Oxygen Saturation
MAUDE report 11766705 ↗
Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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