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

Model Number	1099970
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Malaise (2359)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the elegance nebulizer device had mold in the device and in the patient's tracheostomy tube.It was alleged the device caused non-serious injuries of feeling "unwell" once the patient restarted using the device.The patient reported having medical intervention of "sputum culture, changed trach tube, increased chest physio to clear the sputum load, and was given a nebulizer via ward device".The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Correction to box b: outcomes attributed to ae.'required intervention' should not have been selected.

• 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: 21118498
• Report Number: 2518422-2025-100320
• Device Sequence Number: 8732903
• Product Code: CAF
• UDI-Device Identifier: 00383730001678
• UDI-Public: (01)00383730001678
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: Health Professional
• Device Model Number: 1099970
• Device Catalogue Number: 1099970
• Device Lot Number: 201211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female