Alice NightOneRecalls & reported problems across all models

We found 3 models of Alice NightOne by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2021 and Jan 27, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Alice NightOne problems

Alice NightOne models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alice NightOne Alice NightOne System, Nonin, NA

  VENTILATORY EFFORT RECORDER
  14 reports
• Alice NightOne Alice NightOne Wireless Device, INTL

  VENTILATORY EFFORT RECORDER
  5 reports
• Alice NightOne Alice NightOne System, NA

  VENTILATORY EFFORT RECORDER
  2 reports

Recent Alice NightOne adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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