DreamStation 01 (REF CNX1030T17)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959425347), received between Feb 3, 2025 and Sep 14, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “No Device Output” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 14, 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. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Insufficient Information

  MAUDE report 23047896 ↗
• InjuryFeb 3, 2025No Device Output; No Device Output

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A DREAMSTATION ST30 DEVICE. THERE IS AN ALLEGATION THAT THE DEVICE STOPPED RUNNING WHILE IN USE. THE PATIENT'S BLOOD OXYGEN SATURATION PROGRESSIVELY DECREASED AND CYANOSIS WAS NOT RELIEVED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21300277 ↗

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 Respiron