MAUDE Adverse Event Report: RESPIRONICS, INC. ALICE 6; AUTOMATIC EVENT DETECTION SOFTWARE FOR POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH

Model Number	1063315
Medical Device Problem Codes	Naturally Worn (2988); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the alice 6, base station system, and alice headbox were used with the sleepsense thermistor sensor on the device which caused burns on the face/cheek area of the patient.The thermistor sensor was reportedly completely worn out and exposed internal wires.There were no reports of medical intervention.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted to include the product udi.
Event or Problem Description
This report is being submitted to include the product udi.

• Brand Name: ALICE 6
• Common Device Name: AUTOMATIC EVENT DETECTION SOFTWARE FOR POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH
• 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: 21127217
• Report Number: 2518422-2025-100390
• Device Sequence Number: 6825005
• Product Code: OLZ
• UDI-Device Identifier: 00606959020702
• UDI-Public: (01)00606959020702
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K040595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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: Other
• Device Model Number: 1063315
• Device Catalogue Number: 1063315
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 06/03/2025; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male