MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ELEGANCE; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	1099969
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an innospire elegance device was plugged in and was not in use when the device started smoking.The device was plugged into the receptacle and the ac outlet.There is no smoke smell.There were no reports of melting, warping or voids/gaps in enclosure.There are no allegations of serious or permanent harm or injury.No medical intervention was specified 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.
Additional Manufacturer Narrative
The manufacturer previously reported the manufacturer received information alleging an innospire elegance device was plugged in and was not in use when the device started smoking.The device was plugged into the receptacle and the ac outlet.There is no smoke smell.There were no reports of melting, warping or voids/gaps in enclosure.There are no allegations of serious or permanent harm or injury.No medical intervention was specified by the patient.The innospire elegance was returned to the manufacturer service center for evaluation, and the customer's complaint was not confirmed.During the evaluation it was noted the whole interior was contaminated and the motor had rust on it.No burnt odor was smelled on the inside or outside of the device.Due to the observation of interior contamination, it could be possible a foreign substance got inside the device and was burnt off causing smoke for the customer since rust and contamination was found on the interior of the device.The root cause is not confirmed at this time.A final report is being submitted.If any additional information is received, a supplemental report will be filed.

• Brand Name: INNOSPIRE ELEGANCE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 23845541
• Report Number: 2518422-2025-112859
• Device Sequence Number: 9835514
• Product Code: CAF
• UDI-Device Identifier: 00383730001623
• UDI-Public: (01)00383730001623(21)
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 72 YR
• Patient Sex: Male