MAUDE Adverse Event Report: RESPIRONICS, INC. ELEGANCE NEBULIZER; NEBULIZER SYSTEM, NON-HEATED

Model Number	1099969
Medical Device Problem Codes	Sparking (2595); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device has not yet been returned for evaluation.
Event or Problem Description
The manufacturer received information alleging a thermal event to an elegance nebulizer.The user alleges the device made a popping noise and produced a spark.There was no report of smoke or flames.There was no report of patient harm or injury.The device has not yet been returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: ELEGANCE NEBULIZER
• Common Device Name: NEBULIZER SYSTEM, NON-HEATED
• 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: 17602642
• Report Number: 2518422-2023-20543
• Device Sequence Number: 6307883
• Product Code: BTI
• UDI-Device Identifier: 00383730001623
• UDI-Public: 00383730001623
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 1099969
• Device Catalogue Number: 1099969
• Device Lot Number: 201214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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 Age: 78 YR
• Patient Sex: Male