ComfortGel Blue ComfortGel Blue Nasal Mask w/Headgear, Small, JapanRecalls & reported problems

Respironics, Inc. · ComfortGel Blue Nasal Mask w/Headgear, Small, Japan · 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 00606959043756), received between Jul 24, 2025 and Jul 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Improper or Incorrect Procedure or Method1

Patient problems

Abrasion1
Pressure Sore/Ulcer1

Recent adverse event reports

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

InjuryJul 24, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE MANUFACTURER RECEIVED INFORMATION THAT THE COMFORT GEL BLUE S MASK LEFT SCRATCHES ON THE ALA OF HIS NOSE WHEN HE STARTED TO USE A NEW MASK IN (B)(6). THE PATIENT SAW A DERMATOLOGIST, AND THE DOCTOR DIAGNOSED THE SCRATCHES AS PRESSURE WOUNDS. THIS WAS ASSESSED AS A SERIOUS INJURY. THE CUSTOMER HAS NOT YET RECOVERED FROM THE SYMPTOMS AND SUBMITTED A PHOTO OF THE INJURIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED SERIOUS INJURY. THE USER MANUAL STATES, ¿THE HEADGEAR SHOULD FIT COMFORTABLY, AND THE MASK SHOULD NOT DIG INTO YOUR SKIN. IF YOUR SKIN BULGES AROUND THE MASK OR IF YOU SEE RED MARKS ON YOUR FACE DUE TO TIGHTNESS, LOOSEN THE HEADGEAR.¿ PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Abrasion; Pressure Sore/Ulcer
MAUDE report 22585957 ↗

Device details

UDI-DI	`00606959043756`
Brand	ComfortGel Blue
Model	ComfortGel Blue Nasal Mask w/Headgear, Small, Japan
Catalog no.	1070084
Company	Respironics, Inc.
Product code	BZD · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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 nasal mask, reusable

A flexible, form-shaped device designed to be placed over a user's nose 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. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

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All VENTILATOR, NON-CONTINUOUS (RESPIRATOR) 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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