COMFORTFULL 2 COMFORTFULL 2 MASK with SE, MEDIUM, CHINARecalls & reported problems

Respironics, Inc. · COMFORTFULL 2 MASK with Standard Elbow, MEDIUM, CHINA · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959041820), received between Dec 1, 2025 and Dec 1, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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

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

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available1
Material Integrity Problem1

Patient problems

Discomfort1

Recent adverse event reports

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

InjuryDec 1, 2025Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED DISCOMFORT AND LEAKS FROM A COMFORTFULL MASK. DURING CLINICAL USE OF THE COMFORT FULL 2 NIV (NON-INVASIVE VENTILATION) INTERFACE, IT WAS REPORTED THAT THE PATIENT COMPLAINED OF DISCOMFORT AND WAS NOT COMPLIANT WITH NIV USE. BLOOD GAS LABS WERE CONDUCTED REVEALING CO2 RETENTION. FURTHER EXAMINATION BY THE PHYSICIAN FOUND THAT THE NIV INTERFACE WOULD NOT FIT THE PATIENT CORRECTLY AND DESPITE ADJUSTMENT, UNINTENTIONAL LEAK WAS NOTED RESULTING IN INSUFFICIENT THERAPEUTIC DELIVERY FROM THE DEVICE (UNSPECIFIED MAKE/MODEL). IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOTED TO HAVE BECOME MORE COMPLIANT AND BLOOD GAS RESULTS SHOWED IMPROVEMENT, SUBSEQUENTLY THE PHYSICIAN DECIDED NOT TO REPLACE THE NIV INTERFACE. IT WAS ALLEGED HOWEVER THAT NOTED BLOOD GAS IMPROVEMENTS WERE NOT SIGNIFICANT, RESULTING IN A PROLONGED HOSPITAL STAY FOR THE PATIENT. THE ALLEGATION HAS BEEN REVIEWED BY A PMS CLINICAL EXPERT, AND IT HAS BEEN DETERMINED THERE IS SUFFICIENT EVIDENCE TO PRONOUNCE A SERIOUS INJURY, AS DEFINED IN 21 CFR 803.3(W). NO CAUSAL RELATIONSHIP OF THE DEVICE TO THE PATIENT ADVERSE EVENT WAS NOTED, HOWEVER CONTRIBUTION WAS CO
Patient problems: Discomfort
MAUDE report 23689400 ↗

Device details

UDI-DI	`00606959041820`
Brand	COMFORTFULL 2
Model	COMFORTFULL 2 MASK with SE, MEDIUM, CHINA
Catalog no.	CN1024261
Company	Respironics, Inc.
Product code	CBK · VENTILATOR, CONTINUOUS, FACILITY USE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Oct 14, 2024

Device type (GMDN): CPAP/BPAP face mask, reusable

A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

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All VENTILATOR, CONTINUOUS, FACILITY USE devices →

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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