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

Model Number	1099969
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging dreamstation 2 adv auto cpap device emitted smoke and a smelled like burnt plastic.The patient reports the device caught fire when the patient was using the device.The patient placed the device on the floor because it vibrated, and they started to smell something funny.The patient reports it smelled like burnt plastic and no flames were seen.The patient saw smoke coming from inside the device.The bottom of the device and sides are warped.The vents on the side are melted.The patient reports using a surge protector.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received information alleging dreamstation 2 adv auto cpap device emitted smoke and a smelled like burnt plastic.The patient reports the device caught fire when the patient was using the device.The patient placed the device on the floor because it vibrated, and they started to smell something funny.The patient reports it smelled like burnt plastic and no flames were seen.The patient saw smoke coming from inside the device.The bottom of the device and sides are warped.The vents on the side are melted.The patient reports using a surge protector.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.No device has been returned.No further evaluation is possible at this time.Three attempts to have the device returned for evaluation and investigation were unsuccessful.A final report is being submitted.If new information becomes available that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• 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: 21913100
• Report Number: 2518422-2025-104766
• Device Sequence Number: 21102631
• Product Code: CAF
• UDI-Device Identifier: 00383730001623
• UDI-Public: (01)00383730001623
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 1099969
• Device Catalogue Number: 1099969
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 52 YR
• Patient Sex: Female