AirLife™ AH290 (UDI 10190752144446)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10190752144446), received between Oct 19, 2021 and May 8, 2023 — classified as 8 injuries, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2023Material Separation; Material Separation

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE HUMIDIFICATION CHAMBER, 10/CS BLEW APART (CAME APART) WHILE ON THE PATIENT. THE PATIENT WAS ON 70LPM (LITRES PER MINUTE) AND 80% FIO2 (FRACTION OF INSPIRED OXYGEN). THE PATIENT ALSO EXPERIENCED DESATURATION BUT WAS FINE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16886910 ↗
• InjuryApr 25, 2023Material Separation; Material Separation

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE HUMIDIFICATION CHAMBER, 10/CS CAME APART DURING A HIGH FLOW NASAL CANNULA SYSTEM THAT WAS IN USE ON THE PATIENT. THE PATIENT WAS ON FOR LESS THAN 2 DAYS. THE SETTINGS ON THE HIGH FLOW WERE 50 LPM AT 50%. SINCE THERE IS A 2BESAFE SYSTEM IN THE DEVICE, THE PATIENT WAS NOT INJURED. ( HOWEVER THEY COULD HAVE BEEN BURNED WITH HOT WATER). HE DID HAVE HIS OXYGEN SATURATIONS DROP DOWN TO THE 70¿S BUT RECOVERED QUICKLY ONCE THE SYSTEM WAS REPLACED. THE PATIENT'S RECOVERY WAS IMMEDIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811201 ↗
• InjuryApr 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WATER WAS NOTED TO BE DRIPPING FROM THE SEALANT EDGE OF THE AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER WHERE IT MEETS THE METAL PLATE. WATER WAS FOUND TO BE POOLED ON THE FLOOR, SURROUNDING THE HIGH FLOW MACHINE. THE ELECTRICAL HEATER WIRE AND CIRCUIT APPEARED WET. NO ALARM. END USERS FELT THAT AS THE HUMIDIFICATION BAG FILLED WITH WATER AND EXPANDED, IT CAUSED PRESSURE ON THE HUMIDIFICATION CHAMBER. IT HAPPENED DURING PATIENT USE. INTERVENTIONS INCLUDED REPLACEMENT OF THE HUMIDIFICATION CHAMBER/CIRCUIT AND IMMEDIATE REMOVAL OF THE HIGH FLOW MACHINE FOR CHECKING OF MACHINE AND HEATER WIRES. NO FAULT OF DAMAGE TO MACHINE OR HEATER WIRES REPORTED. THE PATIENT REMAINED STABLE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770405 ↗
• InjuryApr 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WATER WAS NOTED TO BE DRIPPING FROM THE SEALANT EDGE OF THE AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER WHERE IT MEETS THE METAL PLATE. WATER WAS FOUND TO BE POOLED ON THE FLOOR, SURROUNDING THE HIGH FLOW MACHINE. THE ELECTRICAL HEATER WIRE AND CIRCUIT APPEARED WET. NO ALARM. END USERS FELT THAT AS THE HUMIDIFICATION BAG FILLED WITH WATER AND EXPANDED, IT CAUSED PRESSURE ON THE HUMIDIFICATION CHAMBER. IT HAPPENED DURING PATIENT USE. INTERVENTIONS INCLUDED REPLACEMENT OF THE HUMIDIFICATION CHAMBER/CIRCUIT AND IMMEDIATE REMOVAL OF THE HIGH FLOW MACHINE FOR CHECKING OF MACHINE AND HEATER WIRES. NO FAULT OF DAMAGE TO MACHINE OR HEATER WIRES REPORTED. THE PATIENT REMAINED STABLE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770344 ↗
• InjuryApr 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WATER WAS NOTED TO BE DRIPPING FROM THE SEALANT EDGE OF THE AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER WHERE IT MEETS THE METAL PLATE. WATER WAS FOUND TO BE POOLED ON THE FLOOR, SURROUNDING THE HIGH FLOW MACHINE. THE ELECTRICAL HEATER WIRE AND CIRCUIT APPEARED WET. THE MACHINE SQUEALED WITH A LOUD NOISE. END USERS FELT THAT AS THE HUMIDIFICATION BAG FILLED WITH WATER AND EXPANDED, IT CAUSED PRESSURE ON THE HUMIDIFICATION CHAMBER. IT HAPPENED DURING PATIENT USE. INTERVENTIONS INCLUDED REPLACEMENT OF THE HUMIDIFICATION CHAMBER/CIRCUIT AND IMMEDIATE REMOVAL OF THE HIGH FLOW MACHINE FOR CHECKING OF MACHINE AND HEATER WIRES. NO FAULT OF DAMAGE TO MACHINE OR HEATER WIRES REPORTED. THE PATIENT REMAINED STABLE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770322 ↗
• InjuryApr 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WATER WAS OBSERVED TO BE DRIPPING FROM THE SEALANT EDGE OF HUMIDIFICATION CHAMBER, 10/CS WHERE IT MEETS THE METAL PLATE. THE WATER WAS FOUND POOLED ON THE FLOOR, SURROUNDING THE HIGH FLOW MACHINE, ELECTRICAL HEATER WIRE AND CIRCUIT. THE STAFF FELT AS THE HUMIDIFICATION BAG FILLED WITH WATER AND EXPANDED, IT CAUSED PRESSURE ON THE HUMIDIFICATION CHAMBER. THE PATIENTS INVOLVED WERE NEONATAL PATIENTS ¿BABIES OF VARIOUS GESTATION AND AGE/WEIGHT. ALL PRETERM BABIES REQUIRING RESPIRATORY HIGH FLOW SUPPORT (HFT)¿. THEY WERE NOT HARMED SINCE THE FAULTY CHAMBERS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709915 ↗
• InjuryMar 21, 2023Leak/Splash; Material Too Soft/Flexible; Leak/Splash; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THERE WAS A SUBSTANTIAL AMOUNT OF WATER LEAKING ON THE FLOOR FROM TWO IDENTICAL (LOT/BATCH) HUMIDIFICATION CHAMBER, 10/CS UNITS. THE HUMIDITY CHAMBER ALARMED WHEN THE TEMPERATURE EXCEEDED 40 DEGREES CELSIUS. THE MOVEMENT ON THE METAL PLATE WHERE THE CHAMBER PLASTIC IS ATTACHED FELT SOFTER THAN ANTICIPATED. THE PROBLEM HAPPENED WITH THE USE OF TWO DISTINCT PATIENTS MORE THAN TWO DAYS APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583831 ↗
• InjuryMar 21, 2023Leak/Splash; Material Too Soft/Flexible; Leak/Splash; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THERE WAS A SUBSTANTIAL AMOUNT OF WATER LEAKING ON THE FLOOR FROM TWO IDENTICAL (LOT/BATCH) HUMIDIFICATION CHAMBER, 10/CS UNITS. THE HUMIDITY CHAMBER ALARMED WHEN THE TEMPERATURE EXCEEDED 40 DEGREES CELSIUS. THE MOVEMENT ON THE METAL PLATE WHERE THE CHAMBER PLASTIC IS ATTACHED FELT SOFTER THAN ANTICIPATED. THE PROBLEM HAPPENED WITH THE USE OF TWO DISTINCT PATIENTS MORE THAN TWO DAYS APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583769 ↗
• 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 15154021 ↗
• 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 15153865 ↗
• MalfunctionOct 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT THE AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER 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 12661843 ↗