DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3,981 adverse event reports that list this exact device (DI 00606959424197), received between Dec 29, 2022 and Sep 17, 2026 — classified as 30 deaths, 281 injuries, 3,670 malfunctions.

The most frequently reported specific device problem is “Degraded” (3,958 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 3,981 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Degraded

  A DreamStation Auto CPAP device was returned 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, the service technician observed visible foam particles. Additionally, the service technician also noted contamination. The device was scrapped by the service center after the evaluation was completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804392 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES WAS FOUND INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673955 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO 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 PARTICLES. DURING THE EVALUATION, THERE WAS DUST CONTAMINATION FOUND IN THE DEVICE. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673842 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO 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 PARTICLES. DURING THE EVALUATION, THERE WAS DUST CONTAMINATION FOUND IN THE DEVICE. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673828 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672900 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP 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. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED, AND FLUIDS CONTAMINATION WAS FOUND IN THE DEVICE. THE DEVICE WAS SCRAPPED. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670311 ↗
• MalfunctionJun 30, 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 AUTO 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/PARTICLES WAS FOUND INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670309 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP 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. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED, AND HUMIDITY CONTAMINATION WAS FOUND IN THE DEVICE. THE DEVICE WAS SCRAPPED. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670294 ↗
• MalfunctionJun 30, 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. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION AND DUST CONTAMINATION. THE DEVICE HAS BEEN SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669754 ↗
• MalfunctionJun 30, 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. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION AND DUST CONTAMINATION. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE HAS BEEN SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669484 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REPORTED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS OBSERVED INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST CONTAMINATION. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. THERE WAS NO REPORTED PATIENT INVOLVEMENT, INJURY, OR ADVERSE CLINICAL OUTCOME ASSOCIATED WITH THIS EVENT. BASED ON THE IDENTIFICATION OF FOAM DEGRADATION/PARTICLES INSIDE THE BLOWER KIT DURING DEVICE EVALUATION, THIS EVENT WAS DETERMINED TO BE REPORTABLE UNDER FDA 21 CFR PART 803 AS A PRODUCT MALFUNCTION AND/OR POTENTIAL SERIOUS INJURY EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668877 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM PARTICLES WAS OBSERVED INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST CONTAMINATION. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. THERE WAS NO REPORT OF DEATH, SERIOUS OR PERMANENT HARM, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. BASED ON THE IDENTIFICATION OF FOAM PARTICLES INSIDE THE BLOWER KIT DURING DEVICE EVALUATION, THIS EVENT WAS DETERMINED TO BE REPORTABLE UNDER FDA 21 CFR PART 803 AS A PRODUCT MALFUNCTION AND/OR POTENTIAL SERIOUS INJURY EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668874 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REPORTED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS OBSERVED INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED FLUID CONTAMINATION. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. THERE WAS NO REPORTED PATIENT INVOLVEMENT, INJURY, OR ADVERSE CLINICAL OUTCOME ASSOCIATED WITH THIS EVENT. BASED ON THE IDENTIFICATION OF FOAM DEGRADATION/PARTICLES INSIDE THE BLOWER KIT DURING DEVICE EVALUATION, THIS EVENT WAS DETERMINED TO BE REPORTABLE UNDER FDA 21 CFR PART 803 AS A PRODUCT MALFUNCTION AND/OR POTENTIAL SERIOUS INJURY EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668872 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS OBSERVED INSIDE THE BLOWER KIT. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE SERVICE TECHNICIAN NOTED TRASH FAIL CONTAMINATION. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. THERE WAS NO REPORT OF DEATH, SERIOUS OR PERMANENT HARM, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE OBSERVED TRASH FAIL CONTAMINATION WAS UNRELATED TO THE REPORTABLE MALFUNCTION AND WAS NOT DETERMINED TO HAVE CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. BASED ON THE IDENTIFICATION OF FOAM DEGRADATION/PARTICLES INSIDE THE BLOWER KIT DURING DEVICE EVALUATION, THIS EVENT WAS DETERMINED TO BE REPORTABLE UNDER FDA 21 CFR PART 803 AS A PRODUCT MALFUNCTION AND/OR POTENTIAL SERIOUS INJURY EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668870 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REPORTED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS OBSERVED INSIDE THE BLOWER KIT. BLOWER FOAM DEGRADATION (BLFM) WAS ALSO IDENTIFIED. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST CONTAMINATION. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. THERE WAS NO REPORTED PATIENT INVOLVEMENT, INJURY, OR ADVERSE CLINICAL OUTCOME ASSOCIATED WITH THIS EVENT. BASED ON THE IDENTIFICATION OF FOAM DEGRADATION/PARTICLES AND BLOWER FOAM DEGRADATION DURING DEVICE EVALUATION, THIS EVENT WAS DETERMINED TO BE REPORTABLE UNDER FDA 21 CFR PART 803 AS A PRODUCT MALFUNCTION AND/OR POTENTIAL SERIOUS INJURY EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668862 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT AND OBJECT CODE INDICATES THE BLOWER CONTRIBUTED TO THE FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST CONTAMINATION. NO ERROR CODES FOUND. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668010 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666705 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666684 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT AND EVIDENCE OF BLOWER FOAM DEGRADATION. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED FLUIDS FAIL CONTAMINATION AND A DESTROYED/CUT POWER CONNECTOR. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. THERE WAS NO REPORT OF DEATH, SERIOUS OR PERMANENT HARM, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE OBSERVED FLUIDS FAIL CONTAMINATION AND DESTROYED/CUT POWER CONNECTOR WERE UNRELATED TO THE REPORTABLE MALFUNCTION AND WERE NOT DETERMINED TO HAVE CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. BASED ON THE IDENTIFICATION OF VISIBLE FOAM PARTICLES AND BLOWER FOAM DEGRADATION DURING DEVICE EVALUATION, THIS EVENT WAS DETERMINED TO BE REPORTABLE UNDER FDA 21 CFR PART 803 AS A PRODUCT MALFUNCTION AND/OR POTENTIAL SERIOUS INJURY EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665759 ↗
• MalfunctionJun 30, 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. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION AND DUST CONTAMINATION. THE DEVICE HAS BEEN SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664472 ↗
• MalfunctionJun 30, 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 AUTO 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 INSIDE THE BLOWER KIT. MOREOVER, THE DEVICE HAD DUST CONTAMINATION. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664306 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED EVIDENCE OF FOAM DEGRADATION/PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE SERVICE TECHNICIAN ALSO OBSERVED DUST CONTAMINATION AND A DESTROYED POWER CONNECTOR. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662897 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP 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 PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED DUST FAIL. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE VALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662307 ↗
• MalfunctionJun 30, 2026Degraded

  A DREAMSTATION AUTO CPAP 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 PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED DUST FAIL. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662224 ↗
• MalfunctionJun 29, 2026Degraded

  A DREAMSTATION AUTO CPAP 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 PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662035 ↗