DreamWear DreamWear Under Nose Mask, M Frame w/Headgr, GlobalRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959030916), received between Nov 8, 2018 and Nov 17, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Emits Odor” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Nonstandard Device; Device Emits Odor; Failure to Shut Off

  PHILLIPS RESPIRONICS DREAM STATION AUTO WITH HEATED HUMIDIFIER: DEVICE RAN OUT OF WATER BUT FAILED TO STOP RUNNING HUMIDIFIER (INCLUDED INSTRUCTIONS STATE THE HUMIDIFIER FUNCTION SHUTS OFF IF IT RUNS DRY). WOKE TO BURNING SMELL AND REALIZED I HADN'T DREAMED THE SMELL BUT COULDN'T WAKE ENOUGH TO REALIZE THE DANGER OF THE SITUATION. DEVICE COULD HAVE CAUGHT FIRE. ALSO FROM BEGINNING OF USE I HAD DAILY HEADACHES AND BEGAN NOTICING BREATHING ISSUES. I HAVE ASTHMA SO I ATTRIBUTED THE WORSENING CONDITION TO THE ASTHMA. SINCE (B)(6) I HAVE BEEN TRYING UNSUCCESSFULLY TO GET MY MONEY RETURNED FOR THIS DEFECTIVE AND DANGEROUS DEVICE. (B)(6) REFUSED A REFUND STATING PHILLIPS WAS HANDLING REFUNDS DUE TO THE RECALL. I HAVE MADE NUMEROUS CONTACTS. I AM ALWAYS TOLD AN ESCALATION FORM IS BEING COMPLETED AND I WILL BE CONTACTED. IT IS NOW (B)(6) AND NO ONE HAS EVER MADE AN EFFORT TO UPDATE ME OR GET ME A MAILER AND SHIPPING LABEL AND A REFUND. FIRST AVAILABLE PULMONARY FUNCTION TEST IS (B)(6) 2022. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Dyspnea; Headache

  MAUDE report 12835285 ↗
• InjuryNov 8, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  AN END USER ALLEGED HE DEVELOPED A "FOOT INFECTION" WHILE USING A DREAMWEAR NASAL MASK, DREAMSTATION AUTO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE, AND ASSOCIATED HUMIDIFIER. THE USER STATED THE MATERIALS IN THE MASK CAUSED REDNESS TO HIS FACE, AND SUBSEQUENTLY HE DEVELOPED AN INFECTION IN HIS FOOT AFTER USING THE DEVICES FOR ONE WEEK. THE USER REPORTED BEING GIVEN ANTIBIOTICS AND HAS SINCE RECOVERED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 8052033 ↗