MAUDE Adverse Event Report: RESPIRONICS, INC. I-NEB CF UK UNIT; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	1083220
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted regarding an i-neb cf uk unit that is not functioning properly, which is affecting the patient receiving treatment.The patient reports that the treatment takes more than 10 minutes to complete, and there are times when it does not finish at all.The patient has mentioned that he sometimes gives up because the treatment takes too long.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 that the manufacturer was contacted regarding an i-neb cf uk unit that is not functioning properly, which is affecting the patient receiving treatment.The patient reports that the treatment takes more than 10 minutes to complete, and there are times when it does not finish at all.The patient has mentioned that he sometimes gives up because the treatment takes too long.Despite good faith effort attempts made by the manufacturer, the device has not yet been returned for evaluation.There has been no communication from the customer on the return of the device.At this time, philips is not able to fully investigate this complaint.A final report is being submitted.If any additional information is received, a supplemental report will be filed.Section product udi in box d, report source in box g and box h has been updated /corrected in this report.
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 CF UK UNIT
• 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: 21318539
• Report Number: 2518422-2025-101715
• Device Sequence Number: 12916757
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/09/2026; Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/10/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2018
• 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