AMARA AMARA MASK with RS FRAME AND RS Headgear, Small, USRecalls & reported problems
Respironics, Inc. · Amara Mask with RS Frame and RS Headgear, USA, Small, · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959006508), received between Feb 25, 2022 and Feb 25, 2022 — classified as 1 death.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Respiratory Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 25, 2022Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
THE MANUFACTURER BECAME AWARE THAT A USER WAS BEING TRANSFERRED VIA AMBULANCE TO HER HOME FOR HOSPICE CARE. THE USER WAS ON A HOSPITAL BIPAP MACHINE AND MASK AND TRANSFERRED TO HER OWN BIPAP WITH A NEW AMARA VIEW FULL FACE MASK FOR HOME USAGE. THE EMS PERSONNEL ALLEGEDLY DID NOT REMOVE THE CLEAR PLASTIC SHROUD/ LINER FROM THE MASK BEFORE PLACING IT ON THE USER. IN THE FOLLOWING MINUTES, THE USER ALLEGEDLY SUFFOCATED TO DEATH WITH ALL THE MEDICAL PERSONNEL IN THE SAME ROOM. IT IS UNKNOWN THE TYPE AND MANUFACTURER OF THE BIPAP MACHINE AND THE SETTINGS OF THE DEVICE AT THE TIME OF DEATH. THE INVESTIGATION IS ON-GOING. A FOLLOW UP FINAL WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Patient problems: Respiratory Arrest
MAUDE report 13607497 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
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- 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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