DreamStation DreamStation BiPAP S/T 30, GBRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00606959425989), received between Sep 18, 2024 and Mar 9, 2026 — classified as 17 deaths, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K102465); they may or may not involve this specific model.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• DeathMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A DEATH OF A PATIENT OF A DREAMSTATION ST30 DEVICE. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE AT THE TIME OF THE ALLEGATION. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 24546495 ↗
• DeathDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A DREAMSTATION ASV DEVICE HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED. THEREFORE, BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. A REPORT WILL THEN BE FILED WITH ALL REGULATORY AGENCIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.

  Patient problems: Insufficient Information

  MAUDE report 23697620 ↗
• DeathNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION ST30 DEVICE. THE PATIENT HAS PASSED AWAY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557496 ↗
• DeathOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A DREAMSTATION ST30 DEVICE IS BEING RETURNED DUE TO THE USER PASSING AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, THERE IS NO CUSTOMER CONTACT INFORMATION AVAILABLE; THEREFORE, NO GOOD FAITH-EFFORT ATTEMPTS CAN BE MADE, AND PHILIPS IS NOT ABLE TO FULLY INVESTIGATE THIS COMPLAINT. IF ANY ADDITIONAL INFORMATION IS RECEIVED OR THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Insufficient Information

  MAUDE report 23407366 ↗
• DeathSep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A DREAMSTATION ST30 HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.

  Patient problems: Insufficient Information

  MAUDE report 22958803 ↗
• DeathSep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A DREAMSTATION ST30 DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. NO MEDICAL INTERVENTION WAS SPECIFIED THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER DID NOT RECEIVE CONTACT INFORMATION TO OBTAIN ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Insufficient Information

  MAUDE report 22951838 ↗
• DeathAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A DREAMSTATION ST30 HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.

  Patient problems: Insufficient Information

  MAUDE report 22845479 ↗
• MalfunctionJun 30, 2025Smoking; Smoking

  THE MANUFACTURER BECAME AWARE OF A DREAMSTATION ST30 DEVICE ALLEGING THE UNIT HAD 2 ERROR CODES AND SMOKE DAMAGE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE ERROR CODES (#20 AND #226) WERE CONFIRMED AND CLEARED. THE SMOKE DAMAGE WAS ALSO CONFIRMED AND THERE WAS CORROSION ON THE DC INPUT JACK. THE THIRD-PARTY SERVICE CENTER WAS UNABLE TO COMPLETE THE INVESTIGATION, AND THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY (PIL) AND INVESTIGATED FURTHER. 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 22360817 ↗
• DeathJun 26, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  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 REPORTER HAS ALLEGED THAT THE PATIENT HAS SADLY PASSED AWAY. THERE WAS NO MEDICAL INTERVENTION 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338536 ↗
• DeathJun 26, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  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 REPORTER HAS ALLEGED THAT THE PATIENT SADLY PASSED AWAY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN CONFIRMED NO FAULT FOUND AND PASSED ALL TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338356 ↗
• DeathMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS NOTIFICATION IS BEING REVIEWED DUE TO A USER OF A DREAMSTATION AUTO CPAP. IT HAS BEEN REPORTED THE PATIENT HAS SADLY PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 22026387 ↗
• DeathMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN UNSPECIFIED MALFUNCTION RESULTING IN A PATIENT DEATH. DEVICE SETTINGS WERE PROVIDED AS THE FOLLOWING: MODE ST, IPAP 30, EPAP 6, TI. 1.3, RATE 16, RISE 1, RAMP OFF, HUMIDIFICATION 3, TRIGGER AUTO TRAK, 3 L/MIN VIA O2 CONCENTRATOR. ALARMS WERE NOTED AS BEING TURNED OFF. THE CAUSE OF DEATH WAS REPORTED AS CURRENTLY AWAITING A CORONER'S REPORT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 21719312 ↗
• DeathJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DREAMSTATION ST30 DEVICE WAS BEING RETURNED DUE TO THE USER PASSING AWAY. THERE IS NO ALLEGATION OF MALFUNCTION, OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. THE CAUSE OF DEATH WAS NOT PROVIDED. AT THIS TIME, THE DEVICE WAS RETURNED AND A FOLLOW-UP WILL BE FILED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 21288979 ↗
• DeathJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A DREAMSTATION ST30 DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 21286401 ↗
• DeathDec 11, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION THAT A RENTAL, DREAMSTATION ST30, DEVICE IS RETURNING DUE TO A PATIENT PASSING AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE COMPLAINT REVIEW HAS DETERMINED THAT DUE TO INSUFFICIENT INFORMATION THIS WILL BE REPORTED. ALTHOUGH THERE IS NOT AN ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE MENTIONED "DEATH". THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 20907025 ↗
• DeathNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A DREAMSTATION ST30 DEVICE IS RETURNING DUE TO A PATIENT PASSING AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE COMPLAINT REVIEW HAS DETERMINED THAT DUE TO INSUFFICIENT INFORMATION THIS WILL BE REPORTED. ALTHOUGH THERE IS NOT AN ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE MENTIONED "DEATH". THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 20738327 ↗
• DeathOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A DREAMSTATION ST30 DEVICE HAS PASSED AWAY AND THE EQUIPMENT WAS BEING RETURNED. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED. NO FAULTS WERE REPORTED. THERE WERE 632 BLOWER HOURS WITH NO LOGGED ERRORS. THE USER INTERFACE PANEL MAIN AND ALARM RIBBON CABLE HAD DAMAGE. THE USER INTERFACE PANEL WAS REPLACED. THE FINE AND POLLEN FILTERS WERE REPLACED. THE DEVICE WAS CLEANED AND PASSED ALL TESTS. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Insufficient Information

  MAUDE report 20384335 ↗
• DeathSep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT PASSED AWAY AND THE DEVICE WAS GOING TO BE RETURNED AS IT WAS NO LONGER IN USE BY THE CUSTOMER. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE PATIENT OUTCOME, HOWEVER LIMITED INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 20248740 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102465. One submission often covers many models, so check the product and lot details in each record.

• Z-1973-2021 · Jun 14, 2021 · Open, Classified
  DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironic