DreamStation 00 (REF DEX1130S13)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959426313), received between Sep 10, 2024 and Sep 10, 2024 — classified as 2 malfunctions.

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 16, 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.

• MalfunctionSep 10, 2024Degraded; No Apparent Adverse Event; Degraded; No Apparent Adverse Event

  THIS REPORT IS BEING SUBMITTED TO CORRECT THE DESCRIPTION OF THE EVENT OR PROBLEM PREVIOUSLY REPORTED. THE DREAMSTATION BIPAP S/T WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE SHOWED NO SIGNS OF FOAM DEGRADATION. FURTHERMORE, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE MALFUNCTIONED IN A WAY THAT COULD LEAD TO DEATH OR SERIOUS INJURY IF THE ISSUE WERE TO RECUR. THEREFORE, THIS COMPLAINT IS NOT REPORTABLE TO ANY REGULATORY AGENCIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181208 ↗
• MalfunctionSep 10, 2024Degraded; No Apparent Adverse Event; Degraded; No Apparent Adverse Event

  THE CUSTOMER RETURNED THE DEVICE WITH AN ALLEGATION THAT THE DEVICE FOAM NEEDED REPLACED IN RELATION TO THE DEVICE RECALL. 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 REGARDING THE FOAM RECALL. THE MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180938 ↗

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