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

Model Number 1133948

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device evaluated by third party service center.

Event 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
• Type of Device: 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
• MDR Text Key: 332778580
• Report Number: 2518422-2024-02244
• Device Sequence Number: 1
• Product Code: MNR
• UDI-Device Identifier: 00606959047341
• UDI-Public: 00606959047341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• 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
• Device Operator: Other
• Device Model Number: 1133948
• Device Catalogue Number: 1133948
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1