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

Model Number	1133948
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer previously reported regarding the alleging that a patient claims they were burned by the effort belt of alice nightone.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.An alice nightone was returned to the manufacturer product investigation laboratory (pil).During evaluation, the manufacturer product investigation laboratory (pil) was unable to confirm the reported complaint that the patient was burned by the unit.The alice nightone (ano) device was received without customer batteries, a battery cover, or a spo2 sensor, but included a durabelt (sn (b)(6)) and an alice nightone nonin spo2 assembly (sn (b)(6)).No physical damage or defects were observed on any of the components.Correction/removal activities have been initiated (refer to h.9), and complaint code trending is reviewed on a periodic basis to evaluate field quality performance and as an input to risk management activities.Section age in box a, event date in box b, model number, and product udi in box d have been updated/corrected in this report.
Event or Problem Description
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.

• 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: 23663030
• Report Number: 2518422-2025-112151
• Device Sequence Number: 18716694
• Product Code: MNR
• UDI-Device Identifier: 00606959047341
• UDI-Public: (01)00606959047341
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/27/2026

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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2017
• 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 Age: 44 YR
• Patient Sex: Unknown