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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959030787), received between Dec 10, 2020 and Jul 10, 2024 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP/ BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING TO HAVE A RASH AND BUMPS ON THE BACK OF HER HEAD NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19707854 ↗
• MalfunctionDec 22, 2022Device Emits Odor

  RE: PHILIPS RESPIRONICS DREAMWEAR, UNDER THE NOSE NASAL MASK (HEADGEAR, CUSHION, HOSE) TOXIC SMELL I RECEIVED A NEW SHIPMENT OF PERIODIC CPAP SUPPLIES FROM MY HOME MEDICAL EQUIPMENT SUPPLIER, PERFORMANCE HOME MEDICAL, ABOUT DECEMBER 14. THE PACKING SLIP HAS AN ORDER # 1204773, SALES ID (B)(6), DATE ORDERED (B)(6) 2022, DATE SHIPPED (B)(6) 2022. UPON USE THAT EVENING I NOTICED A VERY STRONG TOXIC ODOR. BECAUSE I WAS EXCITED TO RECEIVE A PROPER FITTING SMALL SIZE TO REPLACE THE MEDIUM SIZE I HAD RECEIVED FREE DURING A FITTING AT MY DOCTOR'S OFFICE I USED IT ANYWAY. HOWEVER, THE STRONG, DISTURBING ODOR PREVENTED SLEEP, SO I ABANDONED IT AFTER A FEW HOURS. THE NEXT DAY I WASHED THE MASK, CUSHION AND HOSE AND TRIED AGAIN THAT NIGHT. THE ODOR WAS CUT IN HALF, BUT AFTER A BIT I QUIT USING IT DUE TO FEAR OF HARM. NO PATIENT SHOULD BE EXPOSED TO OFF-GASSING. THE SMELL WAS SOMETHING YOU MIGHT EXPECT IN AN INDUSTRIAL SHOP, NOT A HOME AND CERTAINLY NOT IN YOUR MEDICAL EQUIPMENT. THE STYLE IS NEW TO ME AS I PREVIOUSLY USED THE PHILIPS RESPIRONICS WISP MASK WHICH NEVER GAVE OFF THIS AWFUL SMELL; NOR DID MY INITIAL PHILIPS RESPIRONICS DREAMWEAR, UNDER THE NOSE NASAL MASK GIVEN TO ME BY MY PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043445 ↗
• InjuryNov 4, 2022Device Emits Odor

  I OPENED A NEW PHILIPS RESPIRONICS C-PAP MASK/ NOSE PIECE AND IT HAD A CHEMICAL ODOR SO BAD THAT WHEN I BEGAN USING IT, I BEGAN TASTING IT. THE AREA ON MY TONGUE AND FRONT TEETH REMAINED WEIRD FEELING, ALMOST NUMB. IT WAS SICKENING AND MADE ME FEEL DIZZY. I HAD TO REMOVE THE MASK AND GO BACK TO USING MY OLD MASK. MASK WAS A DREAMWEAR UNDER THE NOSE NASAL MASK. I HAVE THE 2 BAGS WITH LOT NUMBERS, BUT NOT SURE WHICH WAS THE OLD BAG AND WHICH WAS THE NEW BAG. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Aspiration/Inhalation; Dizziness; Numbness

  MAUDE report 15743999 ↗
• DeathDec 10, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR DEPENDENT PATIENT WAS USING A DREAMWEAR CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE MASK WITH A VENTILATOR. THE CONNECTOR ON THE DREAMWEAR MASK BECAME BROKEN AND WAS UNABLE TO BE REATTACHED FOR USE. ALTHOUGH A DIFFERENT MASK WAS PLACED ON THE PATIENT AFTER THE DREAMWEAR MASK BECAME BROKEN, THE PATIENT SUBSEQUENTLY SUFFERED A HEART CONDITION AND DIED. THE DATE OF THE PATIENT DEATH IS CURRENTLY UNKNOWN. THE DEVICE HAS YET TO BE RETURNED TO MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 10985172 ↗