MAUDE Adverse Event Report: RESPIRONICS, INC. ALICE NIGHTONE; SLEEP STUDY MONITOR

Model Number	1133948
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
A stardust 3 device was returned to a service center for evaluation.During the evaluation of the device, 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 customer complaint is confirmed: cable nonin spo2 exposed; in addition, the cannula is contaminated, and the unit needs cleaning.No death, serious harm, or injury was reported.Analysis of past events does not indicate that an adverse event has occurred due to the reported allegation or would be likely to occur if the product allegation were to recur.In addition, a review of the risk file indicates that the potential for a serious adverse event occurring as a result of this incident is unlikely.This event is not reportable under fda 21 cfr part 803, as it does not meet the criteria for a death, serious injury, and/or reportable product malfunction.

• Brand Name: ALICE NIGHTONE
• Common Device Name: SLEEP STUDY MONITOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 21972124
• Report Number: 2518422-2025-105276
• Device Sequence Number: 18251897
• Product Code: MNR
• UDI-Device Identifier: 00606959047341
• UDI-Public: (01)00606959047341
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1133948
• Device Catalogue Number: 1133948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown