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

Model Number	1133948
Medical Device Problem Codes	Failure to Power Up (1476); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer became aware of an allegation of device shuts down and overheats.There was no serious patient harm or injury reported.The device has not yet been returned to the manufacturer.The manufacturer's investigation is on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer was previously received information of an alleging of device shuts down and overheats.There was no serious patient harm or injury reported.The device has not yet been returned to the manufacturer.The manufacturer's investigation is on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.The manufacturer received new and relevant information on 08/14/2024.The device was returned for lab investigation by pil.During the external and internal investigation, it was found no defects or damage.The device was taken apart to look for thermal damage.No thermal damage was found.After putting the ano back together with fully charged batteries, a known good finger sensor was installed, and the ano was connected to a pc and accessed using sleepware g3 software.It was configured and then functionally tested with an anticipated study time of approximately 15 hours by simulating inputs to the ano.Unfortunately, the batteries lasted only 4 hours and 58 minutes.After that time, the device was connected to a pc, and the data stored on the device was downloaded and reviewed.The ano did collect good data for the study.An interesting observation was that one battery was measured at 1.1vdc and the other battery was 0.0vdc.During this study, a thermal imager was used to record the ano¿s temperatures.The highest recorded temperature was 31.7°c or 89°f recorded on the top enclosure.According to the alice night one provider manual, ref (b)(4) r01, the operational temperature range for an ano is +5°c to +35°c.The ano was retested with a fresh set of fully charged batteries.Once again, the device was connected to a pc, and the data stored on the device was downloaded and reviewed.This study only lasted 6.5 hours.All temperature readings were consistent with the first study¿s numbers.The ano collected good data per the g3 software data.Once again, one battery was measured at 1.1vdc and the other battery was 0.0vdc.In addition, appropriate code updated/corrected in this follow-up report.The udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.

• Brand Name: ALICE NIGHTONE
• Common Device Name: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18608806
• Report Number: 2518422-2024-05057
• Device Sequence Number: 2845281
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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