MAUDE Adverse Event Report: RESPIRONICS, INC. I-NEB CYSTIC FIBROSIS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	1083220
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to an i-neb cf device.The manufacturer received information alleging the device was not creating any vapor and medication remaining in the chamber after 10 minutes of use.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device normally completes a treatment within 3 to 4 minutes.The patient has been using a different device to complete treatments.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 i-neb cf device.The manufacturer received information alleging the device was not creating any vapor and medication remaining in the chamber after 10 minutes of use.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device normally completes a treatment within 3 to 4 minutes.The patient has been using a different device to complete treatments the device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Update: manufacturer tab: section h: evaluation method code updated.Evaluation results code updated.Component code updated.Conclusion code updated.
Additional Manufacturer Narrative
The manufacturer previously reported maximum good faith effort attempts to retrieve the device for evaluation.Upon further review of this complaint, analysis of past events has not indicated an adverse event has occurred due to the alleged malfunction.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.This complaint is considered not reportable.

• Brand Name: I-NEB CYSTIC FIBROSIS
• 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: 20599290
• Report Number: 2518422-2024-103160
• Device Sequence Number: 12961078
• Product Code: CAF
• UDI-Device Identifier: 00383730000909
• UDI-Public: (01)00383730000909
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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: 1083220
• Device Catalogue Number: 1083220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 07/29/2025; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2019
• 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