DreamWear Full 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959046214), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 death.

The most frequently reported specific device problem is “Contamination” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 13, 2021Contamination; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Contamination; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PATIENT WAS RECEIVING ASSISTED VENTILATION FROM A TRILOGY VENTILATOR DEVICE. THE PATIENT SUFFERED FROM CARDIAC ARREST WHEN THE DREAMWEAR MASK BECAME DISCONNECTED FROM THE PATIENT AND THE PATIENT SUBSEQUENTLY EXPIRED. THE MANUFACTURER HAS REQUESTED THE RETURN OF THE MASK FOR EVALUATION, BUT THE DEVICE HAS NOT YET BEEN RECEIVED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cardiac Arrest

  MAUDE report 11657276 ↗