DreamStation DreamStation Cellular Modem, USRecalls & reported problems
Respironics, Inc. · DreamStation Cellular Modem, US · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959023871), received between May 13, 2024 and May 13, 2024 — classified as 1 injury.
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
- Degraded1
Patient problems
- Asthma1
- Dizziness1
- Eye Irritation1
- Headache1
- Inflammation1
- Nausea1
- Skin Inflammation/ Irritation1
- Unspecified Heart Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2024Degraded; Degraded
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 REPORTER ALLEGED OF HAVING EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, NAUSEA/VOMITING, KIDNEY DISEASE/TOXICITY, LUNG DISEASE, REDUCED CARDIOPULMONARY RESERVE, HEART ATTACK, ASTHMA (NEW OR WORSENING) AND INFLAMMATORY RESPONSE. 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 REPORT WILL BE FILED.
Patient problems: Asthma; Dizziness; Eye Irritation; Headache; Inflammation; Nausea; Skin Inflammation/ Irritation; Unspecified Heart Problem; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem
MAUDE report 19298909 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.