AirLife™ 002003Recalls & reported problems

Vyaire Medical, Inc. · AirLife™ Bubble Humidifier With 3 psi Pressure Relief Valve · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752115200), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Partial Blockage” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Partial Blockage1

Patient problems

Decreased Respiratory Rate1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 5, 2024Partial Blockage; Partial Blockage
CANNISTER HAS PROBLEMS WITH THE POROUS STONE BECOMING BLOCKED AND THE PATIENT NOT GETTING FLOW. PATIENT NOT GETTING FLOW.
Patient problems: Decreased Respiratory Rate
MAUDE report 18843069 ↗

Device details

UDI-DI	`10190752115200`
Brand	AirLife™
Model	002003
Company	Vyaire Medical, Inc.
Product code	BTT · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 23, 2020

Device type (GMDN): Non-heated respiratory humidifier

A device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.

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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.