DreamStation DreamStation Heated Humidifier, DERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959024113), received between Oct 21, 2025 and Nov 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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.

• MalfunctionNov 25, 2025Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED ELECTRICAL SHOCK FROM HEATED TUBING WHILE USING A DREAMSTATION AUTO CPAP DEVICE. THE PATIENT ALLEGES HE SWITCHED BACK TO THE NORMAL TUBING DAYS LATER AND PASSED OUT AND WAS IN THE HOSPITAL FOR 8 HOURS. THE DOCTORS COULDN'T TELL HIM WHAT HAD TAKEN PLACE; HOWEVER, THE PATIENT CLAIM HE HAD A STROKE. THE PATIENT ALSO ALLEGES DEHYDRATION DURING THE THERAPY, THE HUMIDIFIER SETTING WAS ON LEVEL 5, THE MASK TEST SHOWED 100% AND AHI VALUE WAS LESS THAN 5. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) FOR INVESTIGATION. THE DEVICE WAS APPLIED POWER AND VERIFIED AIRFLOW. WHILE VERIFYING AIRFLOW PIL OBSERVED THAT THE PRESSURE READING WAS LOW LIKELY DUE TO THE HUMIDIFIER LID SEAL AND DRY BOX SEAL MISSING FROM THE HUMIDIFIER. USING A KNOWN GOOD, HEATED TUBE PIL VERIFIED THAT THE TUBE FUNCTIONED PROPERLY AND DID NOT OBSERVE ANY TYPE OF SHOCK. DURING THE INVESTIGATION, PIL OBSERVED THE HUMIDIFIER LID SEAL, AND THE DRY BOX SEAL WAS NOT RETURNED WITH THE HUMIDIFIER. A DUST LIKE CONTAMINATION ON THE TOP ENCLOSURE, BOTTOM ENCLOSURE, BOTTOM ENCLOSURE OF THE HUMIDIFIER, BOTTOM PANEL, BACK PANEL, B

  Patient problems: Dehydration; Electric Shock; Stroke/CVA; Syncope/Fainting

  MAUDE report 23653085 ↗
• MalfunctionOct 21, 2025Overheating of Device; Overheating of Device

  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. THIS REPORT WAS RELATED TO A DREAMSTATION HUMIDIFIER. THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT ALLEGING "SLIGHT BURN MARKS" ON THE INSIDE OF THE HUMIDIFIER LID, AND A "HOLE MELTED INTO THE LID SEAL." THE PATIENT ALSO ALLEGES AN ODOR DURING USAGE. NO DEATH, SERIOUS HARM, OR INJURY WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348998 ↗