MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE DELUXE 230V 50HZ INT. UK PLUG; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	1112279
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to an innospire deluxe device with an allegation of delivery issue.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 previously reported information in reference to an innospire deluxe device with an allegation of delivery issue.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The reporter stated another atomizer was needed.Additional information was not able to be obtained as there was no contact information provided for the reporter.A final report is being submitted.If new information becomes available and/or the device is returned and evaluated, a follow-up/supplemental report will be completed.Updated: evaluation results code grid.Evaluation results code grid.Component code grid.Conclusion code grid.

• Brand Name: INNOSPIRE DELUXE 230V 50HZ INT. UK PLUG
• 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: 21287496
• Report Number: 2518422-2025-101488
• Device Sequence Number: 20791134
• Product Code: CAF
• UDI-Device Identifier: 06946159502023
• UDI-Public: (01)06946159502023
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K031413
• 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): 10/03/2025

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: 1112279
• Device Catalogue Number: 1112279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown