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

Model Number	1133948
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device evaluated by third party service center.
Event or Problem Description
The manufacturer received information regarding a alice nightone n.A.Wireless.The device was returned to a third party service center.During inspection burn and smoke found on the device.This report is being submitted for the burning found on the device during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.This incident has been deemed reportable due to the burning found on the device.The customer requested to send devices unrepaired.

• Brand Name: ALICE NIGHTONE N.A. WIRELESS
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18502886
• Report Number: 2518422-2024-02244
• Device Sequence Number: 8146616
• Product Code: MNR
• UDI-Device Identifier: 00606959047341
• UDI-Public: 00606959047341
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2018
• 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