MAUDE Adverse Event Report: RESPIRONICS, INC. I-NEB CF; NEBULIZER

Model Number	1083220
Medical Device Problem Codes	Overheating of Device (1437); Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
Event or Problem Description
The manufacturer received information alleging a faulty i-nebulizer event occurred.The patient states the device would not end treatment and that the device was heating up.The patient confirmed that they were not receiving their full promixin dose.There was no harm or injury reported.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 an i-nebulizer device would not end treatment and that the device was heating up.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 CF
• Common Device Name: NEBULIZER
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18397054
• Report Number: 2518422-2023-37912
• Device Sequence Number: 2759912
• Product Code: CAF
• UDI-Device Identifier: 00383730000909
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 12/12/2023
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2017
• 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 Sex: Unknown