DreamStation Cellular Modem, USRecalls & reported problems
Respironics, Inc. · Cellular Modem, USA · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959049000), received between Apr 6, 2024 and Jan 30, 2025 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
Patient problems
- Asthma1
- No Clinical Signs, Symptoms or Conditions1
- Pulmonary Dysfunction1
- Respiratory Tract Infection1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF CELLULAR MODEM THAT THE PATIENT ALLEGING NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, HYPERSENSITIVITY, NAUSEA / VOMITING, LOSS OF SEPTUM AND CONSTANT DRYNESS OFF NOSE AND BLOODY NOSES THAT EFFECTS DAILY LIFE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21276292 ↗InjuryApr 6, 2024Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO CELLULAR MODEM ALLEGING NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, ASTHMA (NEW OR WORSENING), LUNG DISEASE. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO PATIENT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER.
Patient problems: Asthma; Pulmonary Dysfunction; Respiratory Tract Infection; Skin Inflammation/ Irritation
MAUDE report 19056640 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.