Dorma 100 Dorma 100, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959038424), received between Jul 29, 2021 and Jan 28, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Contamination; Contamination

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A DORMA 100 CPAP DEVICE. THE PATIENT CLAIMS A FAULT OCCURRED WITH THE DEVICE WHICH RESULTED IN THEM INHALING PARTICULATE MATTER THROUGH THEIR NASAL MASK. THE PATIENT ALLEGES NAUSEA, BREATHLESS AND WHEEZING, HEADACHE, TERRIBLE SMELL AND TASTE IN NOSE AND ON SALIVA, CHESTY COUGH, ITCHY EYES, AS WELL AS FEELING ILL AND TIRED. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Breath odor; Cough; Dyspnea; Eye Irritation; Fatigue; Headache; Taste Disorder; Wheezing

  MAUDE report 21260896 ↗
• MalfunctionFeb 24, 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 SEEING BLACK PARTICLES/DOTS ON THE FACE. 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 13592711 ↗
• InjuryJul 29, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LUNG CANCER. THE PATIENT REQUIRED A PARTIAL LOBECTOMY IN RESPONSE TO THE REPORTED EVENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer

  MAUDE report 12246669 ↗
• InjuryJul 29, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LUNG CANCER. THE PATIENT REQUIRED A PARTIAL LOBECTOMY IN RESPONSE TO THE REPORTED EVENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer

  MAUDE report 12246667 ↗

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 provi