Alice NightOne Alice NightOne System, Nonin, NARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00606959047341), received between Jan 12, 2022 and Jan 27, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN ALICE NIGHTONE SLEEP DIAGNOSTICS DEVICE. THE CUSTOMER COMPLAINT WAS UNIT IS NOT RECORDING PROPERLY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE. THE TECHNICIAN REPORTS DAMAGES TO THE SPO2 CABLE (CABLE INSULATION DAMAGE, WIRES EXPOSED, SPLITTING WIRES EXPOSED, CUT CABLE). A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT MAY BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190072 ↗
• MalfunctionJan 20, 2026Material Split, Cut or Torn

  AN ALICE NIGHT ONE SLEEP DIAGNOSTICS DEVICE AS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION RELATED TO THE COMPLAINT OF XPOD WIRE SPLIT OPEN. THE DEVICE WAS VISUALLY INSPECTED. THE SERVICE TECHNICIAN REPORTS EXPOSED OR SPLIT WIRES ON THE SPO2 CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116602 ↗
• MalfunctionJan 17, 2026Material Split, Cut or Torn

  AN ALICE NIGHTONE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER DUE TO AN ALLEGATION THE DEVICE KEPT SHUTTING OFF. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, IT WAS OBSERVED THAT THE SPO2 IS DAMAGED, SPO2 CABLE INSULATION WAS DAMAGED, WIRES WERE EXPOSED, SPLITTING WIRES WERE EXPOSED, CUT CABLE IN THE DEVICE, BOTTOM ENCLOSURE IS BROKEN, THE BATTERY DOOR IS MISSING, AND THE AUXILARY DOOR IS DAMAGED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105160 ↗
• MalfunctionNov 26, 2025Excessive Heating; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PATIENT CLAIMS THEY WERE BURNED BY THE EFFORT BELT OF ALICENIGHTONE.THE PATIENT REPORTED THAT SHE PUT ON THE MACHINE PER THE INSTRUCTIONS FOR ABOUT 5¿9 MINUTES. AROUND 3 A.M., SHE FELT HOT AND NOTICED A SMALL BLISTER ON HER CHEST. THE LOWER LEFT BOTTOM OF THE UNIT WAS VERY HOT.THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663030 ↗
• MalfunctionNov 20, 2025Overheating of Device; Overheating of Device

  AN ALICE NIGHTONE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER WITH AN ALLEGATION OF UNIT STOPS DURING THE NIGHT. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. DURING THE EVALUATION, CUSTOMER'S COMPLAINT WAS CONFIRMED. DURING EVALUATION IT WAS NOTED THAT THE PRINTED CIRCUIT ASSEMBLY HAD ELECTRICAL DAMAGE. IT WAS NOTED THAT THE TOP ENCLOSURE, BOTTOM ENCLOSURE, AUXILLIAR COVER WERE DAMAGED BATTERY AND DOOR WAS MISSING. THE DEVICE WAS SCRAPPED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612359 ↗
• MalfunctionNov 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS NOTIFICATION WAS OPENED TO REVIEW THE ALICE NIGHTONE DEVICE FOLLOWING INFORMATION RECEIVED REGARDING FRAYED WIRE. THE DEVICE HAS NOT YET BEEN EVALUATED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567939 ↗
• MalfunctionJul 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN ALICE NIGHTONE ALLEGING THE DEVICE HAS EXPOSED WIRES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REPORTED. 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 22679376 ↗
• MalfunctionJul 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN ALICE NIGHTONE SLEEP DIAGNOSTIC DEVICE. THE USER ALLEGES EXPOSED WIRES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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 22638068 ↗
• MalfunctionJul 16, 2025Contamination /Decontamination Problem; Material Split, Cut or Torn; Contamination /Decontamination Problem; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN ALICE NIGHTONE DEVICE. THE ALLEGATION IS XPOD WIRE EXPOSED. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION, THE SERVICE TECHNICIAN CONFIRMS THAT THE XPOD WIRE IS EXPOSED AND CONTAMINATION WAS FOUND INSIDE THE DEVICE. THE DEVICE WAS REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522893 ↗
• MalfunctionMay 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO "EXPOSED WIRE". THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. NO OTHER MEDICAL INFORMATION WAS SPECIFIED. 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 21972124 ↗
• MalfunctionMar 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN ALICE NIGHTONE SLEEP DIAGNOSTICS DEVICE. THE USER ALLEGES EXPOSED WIRING AND THE UNIT WILL NOT TURN ON. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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 21677948 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Excessive Heating; Failure to Power Up; Excessive Heating

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF DEVICE SHUTS DOWN AND OVERHEATS. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608806 ↗
• MalfunctionJan 12, 2024Overheating of Device; Smoking; Overheating of Device; Smoking

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A ALICE NIGHTONE N.A. WIRELESS. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING INSPECTION BURN AND SMOKE FOUND ON THE DEVICE. THIS REPORT IS BEING SUBMITTED FOR THE BURNING FOUND ON THE DEVICE DURING SERVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. THIS INCIDENT HAS BEEN DEEMED REPORTABLE DUE TO THE BURNING FOUND ON THE DEVICE. THE CUSTOMER REQUESTED TO SEND DEVICES UNREPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502886 ↗
• MalfunctionJan 12, 2022Battery Problem; Battery Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF THE BATTERY COVER ON THE ALICE NIGHTONE HAD MELTED AND THE BATTERY COIL INSIDE THE DEVICE LOOKED BURNT AND MELTED. THIS EVENT OCCURRED RECORDING A PATIENT STUDY WHILE IN USE. THERE WAS NO SMOKE, FLAME OR VOIDS TO THE OUTER CASING. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235120 ↗