Comfort Classic Comfort Classic Mask with Headgear, Small, IberiaRecalls & reported problems
Respironics, Inc. · Comfort Classic Mask with Headgear, Small, Iberia · 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 00606959023154), received between Nov 11, 2015 and Nov 11, 2015 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Cellulitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2015Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A PATIENT ALLEGES SHE EXPERIENCED AN ALLERGIC REACTION CAUSED BY THE FOREHEAD PAD OF A COMFORT CLASSIC MASK. THERE WAS NO SERIOUS OR PERMANENT INJURY REPORTED, AND NO LOT NUMBER WAS PROVIDED. THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGATION OF "ALLERGIC REACTION" BECAUSE THE MASK REPORTEDLY IN USE WAS DISCARDED BY THE USER, AND NO FURTHER INFORMATION WAS PROVIDED. PRODUCT LABELING FOR THE COMFORT CLASSIC MASK INSTRUCTS THE USER TO "INSPECT THE MASK FOR DAMAGE OR WEAR (CRACKING, CRAZING, TEARS, ETC.). DISCARD AND REPLACE ANY COMPONENTS AS NECESSARY" AND "SOME USERS MAY EXPERIENCE SKIN REDNESS, IRRITATION, OR DISCOMFORT. IF THIS HAPPENS, DISCONTINUE USE AND CONTACT YOUR HEALTHCARE PROFESSIONAL". THE COMFORT CLASSIC MASK MEETS ALL RELEVANT ISO STANDARDS FOR BIOCOMPATIBILITY. BASED ON THE INFORMATION AVAILABLE NO FURTHER ACTION IS NECESSARY.
Patient problems: Cellulitis
MAUDE report 5217216 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
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- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 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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