DreamStation DreamStation Auto CPAP, EURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959027435), received between Oct 9, 2021 and Jan 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE'S THERMAL EVENT. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE DEVICE SMELLS BURNT, HUMIDIFIER NO LONGER RECOGNIZES HEADSET TUBE. ADDITIONALLY, THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION, IT WAS FOUND THAT THE PCA WAS BURNT. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114110 ↗
• MalfunctionJan 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP'S EVENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER. AND IT IS OBSERVED THAT PCA BURNT. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. THE PATIENT 'S REQUIRED NO MEDICAL INTERVENTION. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101963 ↗
• MalfunctionOct 9, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED. THERE WAS NO PATIENT INJURY OR HARM REPORTED. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602229 ↗