DreamStation DreamStation CPAP w/Humidifier, w/Heated Tube, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 275 adverse event reports that list this exact device (DI 00606959424081), received between Oct 19, 2023 and Jun 3, 2026 — classified as 1 death, 43 injuries, 231 malfunctions.

The most frequently reported specific device problem is “Degraded” (275 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 25 most recent of 275 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Degraded

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371454 ↗
• MalfunctionApr 7, 2026Degraded

  A DREAMSTATION CPAP DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803345 ↗
• MalfunctionMar 26, 2026Degraded

  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. A DREAMSTATION CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION WAS FOUND. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697366 ↗
• MalfunctionFeb 27, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470914 ↗
• MalfunctionFeb 20, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398407 ↗
• MalfunctionFeb 20, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398217 ↗
• MalfunctionFeb 20, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398134 ↗
• MalfunctionFeb 19, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387559 ↗
• MalfunctionFeb 18, 2026Degraded

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376480 ↗
• MalfunctionFeb 18, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375920 ↗
• MalfunctionFeb 17, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373818 ↗
• MalfunctionFeb 17, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366629 ↗
• MalfunctionFeb 17, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362411 ↗
• MalfunctionFeb 16, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24359193 ↗
• MalfunctionFeb 16, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343309 ↗
• MalfunctionFeb 16, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342470 ↗
• MalfunctionFeb 4, 2026Degraded

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED. AT THIS TIME, 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 24261007 ↗
• MalfunctionDec 11, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION. IN ADDITION, THE DEVICE DISPLAYED ERROR CODE E130 (ERR_TASK_WDOG_TIMEOUT) RECORDED IN THE ERROR LOG. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778749 ↗
• MalfunctionNov 14, 2025Degraded; Degraded

  A DREAMSTATION CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED AN ERROR CODE PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554701 ↗
• MalfunctionNov 7, 2025Degraded; Degraded

  A DREAMSTATION CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED AN ERROR CODE PRESENT (ERROR 22: ERR_MOTOR_FLUX_MAGNITUDE; ERROR 83: ERR_FSENS_UNABLE_TO_OBTAIN_BUS), SD CARD FOUND, AND SERVICE IS REQUIRED. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499015 ↗
• MalfunctionOct 24, 2025Degraded; Degraded

  A DREAMSTATION CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379551 ↗
• MalfunctionOct 22, 2025Degraded; 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. A DREAMSTATION CPAP DEVICE WAS RETURNED TO A SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM DEGRADATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357245 ↗
• MalfunctionSep 10, 2025Degraded; 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGES CANNOT SLEEP AS DROWN IN LUNGS. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS 1 ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS NO VISIBLE FOAM DEGRADATION AND DEVICE WAS DISPOSITIONED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Pulmonary Edema

  MAUDE report 23014590 ↗
• MalfunctionSep 6, 2025Degraded; 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. THIS REPORT WAS RELATED TO A DREAMSTATION CPAP DEVICE. THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT ALLEGING THAT WHEN HE PUTS THE DEVICE ON ITS TOO HIGH IN HIS NOSE. THE PATIENT STATES HE HAS A DRY MOUTH USING THE DEVICE AND HE USES PILLOWS MASK. THE PRESSURE HAS BEEN HIGH ON HIS DEVICE. HIS WIFE SAYS HE SNORES AND IS A MOUTH BREATHER.MEDICAL INTERVENTION WAS NOT SPECIFIED. 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: Dry Mouth

  MAUDE report 22987888 ↗
• MalfunctionSep 2, 2025Degraded; Degraded

  THIS NOTIFICATION IS BEING REVIEWED DUE TO A USER OF A DREAMSTATION CPAP DEVICE. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED/SCRAPPED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939703 ↗