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

Model Number	1083220
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that the patient's device is signaling the end of treatment after only 2 breaths and most of the medication is remaining in the chamber.As result, the patient reported that he is missing some of his doses and it wasn't happening previously.The patient reported that it was happening with all of the chambers, and he believes it is an issue with the device.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 received information alleging that that the patient's device is signaling the end of treatment after only 2 breaths and most of the medication is remaining in the chamber.As a result, the patient reported that he is missing some of his doses and it wasn't happening previously.The patient reported that it was happening with all of the chambers, and he believes it is an issue with the device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Multiple good faith efforts have been made to obtain additional information, without customer response.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.
Event or Problem Description
The manufacturer received information alleging that that the patient's device is signaling the end of treatment after only 2 breaths and most of the medication is remaining in the chamber.As a result, the patient reported that he is missing some of his doses and it wasn't happening previously.The patient reported that it was happening with all of the chambers, and he believes it is an issue with the device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Multiple good faith efforts have been made to obtain additional information, without customer response.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.
Additional Manufacturer Narrative
The manufacturer previously reported maximum gfe 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
• 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: 21607871
• Report Number: 2518422-2025-103005
• Device Sequence Number: 8796135
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 02/12/2025; Not provided
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 11/06/2025; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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