REMstar SE REMstar SE with Humidifier, with SD Slot, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959020078), received between Apr 7, 2022 and Apr 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

1 other recall cover devices cleared under the same FDA submission (K130077); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2022Degraded; No Apparent Adverse Event; Degraded; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO THE DEVICE GETTING HOT AND BLOWING HOT AIR. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 14046357 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130077. One submission often covers many models, so check the product and lot details in each record.

• Z-1974-2021 · Jun 14, 2021 · Open, Classified
  SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide