DreamWisp FitPack DreamWisp Mask, Med Connector, w/Headgear, GlobalRecalls & reported problems
Respironics, Inc. · FitPack DreamWisp Mask, Med Connector, w/Headgear, Global · Class 2
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 00606959050976), received between Dec 12, 2022 and Dec 12, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Tinnitus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN END USER EXPERIENCES A BUZZING NOISE FROM A COCHLEAR IMPLANT IN LEFT EAR WHILE WEARING THE DREAMWISP NASAL MASK WITH MAGNETIC CLIPS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.
Patient problems: Tinnitus
MAUDE report 15958951 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
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- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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