Alice NightOne Alice NightOne Wireless Device, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00606959039797), received between Oct 20, 2021 and Aug 10, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF ALICE NIGHTONE THAT THE PATIENT ALLEGES THAT THE DEVICE STOPPED RECORDING AFTER 20 MINUTES. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED, DEVICE WAS NOT RECORDING BODY POSITIONING, TOP ENCLOSURE WAS CRACKED, THE SP02 CABLE WAS FAULTY, THE AUX COVER MISSING AND LED LIGHTS FAULTY. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957772 ↗
• MalfunctionAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALICE NIGHTONE DEVICE. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH POSSIBLE FAULT. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE TOP AND BOTTOM ENCLOSURE HAVE CRACKS. THE PCA WAS FAULTY. SPO2 CABLE AND AUX COVER WERE REPLACED. DEVICE READY FOR DISPATCH. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935012 ↗
• MalfunctionAug 7, 2024Adverse Event Without Identified Device or Use Problem; Power Problem; Adverse Event Without Identified Device or Use Problem; Power Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF ALICE NIGHTONE THAT THE PATIENT ALLEGES THE DEVICE WILL NOT POWER UP AND FOUND CRACKED ON TOP ENCLOSURE ON THE DEVICE. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED, THE SIEVE BEDS BLOWN, THE SOLENOID WAS INTERMITTENT, THE REGULATOR WAS DAMAGED, PCA BOARD HAS NON-STOP ALARMING, FLOW METER WAS CRACKED, AND POWER CORD WAS SMASHED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934606 ↗
• MalfunctionAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF ALICE NIGHTONE THAT THE PATIENT SENT IN FOR REPAIR DUE TO CASING DAMAGE. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED, TOP AND BOTTOM CASING TO BE SPLIT AND FLUID INGRESS ON THE PCA, THEREFORE UNABLE TO RETRIEVE ANY INFORMATION FROM THE DEVICE. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934008 ↗
• InjuryOct 20, 2021Battery Problem; Battery Problem

  THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION THAT A USER RECEIVED A BURN INJURY TO THE CHEST WHILE USING THE ALICE NIGHTONE DEVICE. OBSERVATIONS OF POWDER COMING OUT OF THE BATTERY AND PEELING ON THE SURFACE OF THE BATTERY WERE REPORTED. THE PATIENT WAS REPORTEDLY PRESCRIBED OINTMENT FOR THE BURN AND HAS NOT REQUIRED ANY FURTHER INTERVENTION. THE MANUFACTURER HAS REQUESTED RETURN OF THE DEVICE AND ALL ACCESSORIES THAT WERE IN USE AT THE TIME OF THE EVENT, AND THE INVESTIGATION IS ON-GOING. ON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Burn(s)

  MAUDE report 12668285 ↗