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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The manufacturer previously reported information 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 device was returned to a third party service center.During evaluation, the service technician confirmed the cable nonin spo2 was exposed.Additionally, there were some parts of the device that were damaged.The affected parts were replaced.Updated: evaluation method code grid updated.Evaluation results code grid updated.Component code grid updated.Conclusion code grid updated.

• 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: 22679376
• Report Number: 2518422-2025-108502
• Device Sequence Number: 9566087
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 07/22/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 01/16/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown