Skip to content

DreamStation DreamStation Auto CPAP, KRRecalls & reported problems

Respironics, Inc. · DreamStation Auto CPAP, Korea · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959043374), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 malfunction.

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.

Most reported problems

Device problems

  • Degraded1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 10, 2021Degraded; Degraded

    A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE DEVICE'S SOUND ABATEMENT FOAM WAS OBSERVED. 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 12453623 ↗

Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices

All VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page