DreamStation DreamStation Expert w/Humidifier, w/Cell, CARecalls & reported problems
Respironics, Inc. · DreamStation Expert with Humidifier and Cellular modem for Canada · Class 2
All models of Philips DreamStation (190)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Respironics DreamStation Expert is a non-continuous ventilator with a humidifier and cellular modem. The 43 reports mostly describe internal sound-abatement foam breaking down into particles inside the unit, with a few mentioning contamination and symptoms such as shortness of breath, headache, dizziness and nausea. There are 42 malfunctions, one injury and no deaths. No recalls name this device. Reports jumped from 1 in the prior 12 months to 29 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00606959053175), received between Jul 15, 2021 and Jun 30, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Degraded” (30 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.
Reports received per month
Most reported problems
Device problems
- Degraded30
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Dyspnea3
- Abdominal Pain1
- Cough1
- Dizziness1
- Eye Irritation1
- Headache1
- Nausea1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
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 EXPERT 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. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED FLUID CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670113 ↗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 EXPERT 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. 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 25666227 ↗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 EXPERT 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. 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 25666213 ↗MalfunctionJun 29, 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 EXPERT 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 25660622 ↗MalfunctionJun 29, 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 EXPERT 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 VISIBLE FOAM PARTICLES/ DEGRADATION WAS FOUND INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED FLUIDS CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659713 ↗MalfunctionJun 29, 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 EXPERT 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 25658635 ↗MalfunctionJun 29, 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 EXPERT 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. 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 25656456 ↗MalfunctionJun 24, 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 EXPERT 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 25612700 ↗MalfunctionJun 22, 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 EXPERT 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. 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 25585327 ↗MalfunctionJun 18, 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 EXPERT DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT AND ALSO NOTED BLOWER FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN FOUND 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 25548410 ↗MalfunctionJun 9, 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 EXPERT 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. 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 25446792 ↗MalfunctionJun 9, 2026Degraded
A DREAMSTATION EXPERT 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. IN ADDITION, FOAM PARTICLES INSIDE THE BLOWER KIT AND DUST WERE FOUND IN CONTAMINATION FINDINGS. ADDITIONALLY, THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446274 ↗MalfunctionJun 9, 2026Degraded
A DREAMSTATION EXPERT 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. IN ADDITION, FOAM PARTICLES INSIDE THE BLOWER KIT AND DUST WERE FOUND IN CONTAMINATION FINDINGS. ADDITIONALLY, THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446272 ↗MalfunctionMay 20, 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 EXPERT 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. 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 25232767 ↗MalfunctionMay 14, 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. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174461 ↗MalfunctionMay 12, 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. 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 25153493 ↗MalfunctionNov 13, 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 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM PARTICLES OR DEGRADATION. IN ADDITION, THE DEVICES ERROR LOG WAS DOWNLOADED, AND ONE ERROR CODE WAS PRESENT WHEN REVIEWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677176 ↗MalfunctionMar 25, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF HARM OR INJURY. 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 13904494 ↗MalfunctionMar 25, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF HARM OR INJURY. 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 13904484 ↗MalfunctionMar 25, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED SMELLING SMOKE COMING THROUGH HIS BREATH AND A BURNING/SMOKE/ELECTRICAL ODOR. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. 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 13902580 ↗MalfunctionMar 21, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED DIFFICULTY BREATHING/SHORT OF BREATH. PATIENT ALSO ALLEGED THAT THE DEVICE HAS A STRANGE ODOR. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Dyspnea
MAUDE report 13841038 ↗MalfunctionMar 21, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND OBSERVED HUMIDIFIER DURING DEVICE EVALUATION THERE WAS NO ALLEGATION OF HARM OR INJURY. 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 13840292 ↗MalfunctionMar 2, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING PARTICLES IN THE AIR PATH. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 13654721 ↗MalfunctionFeb 21, 2022Contamination; Degraded; Contamination; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF BLACK PARTICLES IN FILTER, SHORTNESS OF BREATH AND COUGH. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Cough; Dyspnea
MAUDE report 13568388 ↗InjuryDec 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP SEVERE PAIN AND UPSET STOMACH. THE PATIENT WAS HOSPITALIZED IN RESPONSE TO THE REPORTED EVENT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Abdominal Pain
MAUDE report 13092960 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
- REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)117 deaths10,075 reports
- DreamStation DreamStation Auto BiPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)106 deaths5,937 reports
- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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