MAUDE Adverse Event Report: RESPIRONICS, INC. ALICE NIGHTONE; VENTILATORY EFFORT RECORDER

Model Number	1133948
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The manufacturer previously reported 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).Correction: this event is no longer considered reportable based on the risk assessment.

• Brand Name: ALICE NIGHTONE
• Common Device Name: VENTILATORY EFFORT RECORDER
• 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: 24190072
• Report Number: 2518422-2026-003317
• Device Sequence Number: 8009948
• Product Code: MNR
• UDI-Device Identifier: 00606959047341
• UDI-Public: (01)00606959047341
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 1133948
• Device Catalogue Number: 1133948
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2019
• 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