DreamStation 00 (REF FRX500S14)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00606959023574), received between Sep 28, 2016 and Mar 13, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 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. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THIRD PARTY SERVICE CENTER AND EVALUATED. EVALUATION RESULT STATED THAT FOAM PARTICLES WERE OBSERVED. THE DEVICE HAS BEEN SCRAPPED. ADDITIONALLY, TOBACCO CONTAMINATION WAS PRESENT INSIDE THE DEVICE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594483 ↗
• MalfunctionDec 31, 2024Degraded; Degraded

  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. THERE WAS NO REPORT 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 FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED. THERE WAS NO INFORMATION ABOUT PRODUCT RETURNED DATE AND TIME. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046609 ↗
• MalfunctionNov 11, 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 AN ISSUE RELATED TO A DREAMSTATION AUTO DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED COUGHING, CHEST PAIN, SKIN AND EYE IRRITATION. THERE WAS NO REPORT OF HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN COULD NOT CONFIRM FOAM PARTICLES IN THE DEVICE EVALUATION. THE DEVICE WAS SCRAPPED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Chest Pain; Cough; Eye Irritation; Skin Inflammation/ Irritation

  MAUDE report 20658241 ↗
• MalfunctionNov 8, 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 AN ISSUE RELATED TO A DREAMSTATION AUTO DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED HEADACHE, DIZZINESS, NAUSEA, SEVERE FATIGUE. THERE WAS NO REPORT OF HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN COULD NOT CONFIRM FOAM PARTICLES IN THE DEVICE EVALUATION. THE DEVICE WAS SCRAPPED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Dizziness; Fatigue; Headache; Nausea

  MAUDE report 20639025 ↗
• MalfunctionNov 8, 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 AN ISSUE RELATED TO A DREAMSTATION AUTO DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED HEADACHE AND COUGH. THERE WAS NO REPORT OF HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN COULD NOT CONFIRM FOAM PARTICLES IN THE DEVICE EVALUATION. THE DEVICE WAS SCRAPPED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Cough; Headache

  MAUDE report 20639024 ↗
• MalfunctionSep 14, 2023Degraded; 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 "HEADACHES, COUGHING, RESPIRATORY DISCOMFORT, CONGESTED BRONCHI ITCHING, GREAT FATIGUE IMPACT ON BLOOD PRESSURE STOP RESPIRATORY ASSISTANCE." NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cough; Fatigue; Headache; Unspecified Respiratory Problem

  MAUDE report 17745486 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS MADE AWARE THAT AN END USER ALLEGED SHE WAS "POISONED" BY USING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE. THE END USER REPORTS BEING HOSPITALIZED. THE DATE OF THE ALLEGED EVENT, DATE OF ADMISSION, ADMITTING DIAGNOSIS, TREATMENT REQUIRED, AND LENGTH OF STAY ARE UNKNOWN AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE CPAP AND ASSOCIATED HUMIDIFIER INDICATE THEY PASSED ALL TESTING AND FUNCTIONED AS DESIGNED PRIOR TO LEAVING THE MANUFACTURING FACILITY. A SEARCH OF THE MANUFACTURER'S COMPLAINT SYSTEM INDICATES NO SIMILAR REPORTS OF "POISONING" OCCURRING WITH THESE DEVICES. THE MANUFACTURER REQUESTED RETURN OF THE DEVICES FOR EVALUATION, AND ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Patient Involvement; Toxicity

  MAUDE report 5983274 ↗