MAUDE Adverse Event Report: RESPIRONICS, INC. I NEB; 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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a i-neb device is not working.The device is not signaling the end of the treatment and there is medication remaining the device's chamber.The patient states they missed their doses of promixin over the weekend and feels it is affecting their chest.The patient tried a replacement chamber, and the issue has not resolved.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 a i-neb device is not working.The device is not signaling the end of the treatment and there is medication remaining the device's chamber.The patient states they missed their doses of promixin over the weekend and feels it is affecting their chest.The patient tried a replacement chamber, and the issue has not resolved.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The previous report did not capture that the device has not yet been returned to the manufacturer for evaluation.At this time, there is no customer contact information available; therefore, no good faith effort attempts can be made, and philips is not able to fully investigate this complaint.If any additional information is received or the device is returned, a supplemental report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported a malfunction with the device.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
• 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: 22137282
• Report Number: 2518422-2025-106341
• Device Sequence Number: 12605753
• 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,Consumer,Distributor
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 11/14/2025; Not provided
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 11/14/2025; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown