DreamStation DreamStation BiPAP autoSV, AURecalls & reported problems
Respironics, Inc. · DreamStation BiPAP autoSV, AU · Class 2
All models of Philips DreamStation (190)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959424838), received between Dec 29, 2024 and Dec 29, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (1 report).
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
- Degraded1
Patient problems
- Lymphoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 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 THE PATIENT RECEIVED RESULTS OF THE CORE BIOPSY SAMPLES TAKEN LAST WEEK FROM A SWOLLEN LYMPH GLAND ON THE PATIENT'S NECK, AND THE RESULTS STATE THAT THE PATIENT'S NON-HODGKIN'S LYMPHOMA HAS RETURNED. THE PATIENT'S ONCOLOGIST PREVIOUSLY DECLARED THE PATIENT LEGALLY CURED FROM NON-HODGKIN'S LYMPHOMA, AND SHOOK THE PATIENT'S HAND ON (B)(6) 2024. THE PATIENT WAS DIAGNOSED WITH CANCER 10 YEARS AGO CAUSED BY GLYPHOSATE, THE MAIN INGREDIENT IN ROUNDUP (WEEDKILLER). THE PATIENT DID NOT USE THE DEVICE IN THE PAST 4 DAYS AFTER READING ABOUT THE RECALL. THE PATIENT RETURNED THE DEVICE AND PURCHASED ANOTHER MANUFACTURER'S DEVICE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Lymphoma
MAUDE report 21032402 ↗
Other VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING devices
- DreamStation BiPAP ST30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING5 deaths547 reports
- DreamStation BiPAP ST30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths283 reports
- BiPAP AVAPS BiPAP AVAPS C Series, 30cm, INTLRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING274 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Humid, 60 Series, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths209 reports
- BiPAP S/T C-Series BiPAP S/T C Series Core Pack, 30cm, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death200 reports
- DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING4 deaths174 reports
- DreamStation BiPAP AVAPS DreamStation AVAPS30 w/Humid w/H Tube w/Cell, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 deaths144 reports
- BiPAP A30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 recalls29 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.
How reports and recalls are matched · Editorial policy · Report an error on this page