Alice NightOne Alice NightOne System, NARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959039810), received between Feb 26, 2025 and Oct 28, 2025 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Degraded; Power Problem; Degraded; Power Problem

  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 PATIENT CLAIMS THAT NOT RECORDING PROPERLY. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF TOP ENCLOSURE ELECTRICAL DEFECT. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD NOT CONFIRMED THE CUSTOMER'S ALLEGATION AND THERE WAS TOP ENCLOSURE ELECTRICAL DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401045 ↗
• MalfunctionFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN ALICE NIGHTONE DEVICE WITH AN ALLEGATION OF EXPOSED WIRE ON THE CORD. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY NO MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS REQUESTED FOR RETURN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472924 ↗