MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS HOME NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	1130530
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a user of a philips home nebulizer device alleging the device is not working and would like a replacement.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 patient using home neb device that is not working and would like a replacement.Based on the information currently provided and available, no harm or injury has been sustained and therefore further analysis of cause and/or contribution of the device to a serious injury or death is not applicable.No further action is required.Clinical assessment team assessed as non-serious injuries.Therefore, the device did not contribute to a serious injury or death.No further action is required.This event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or reportable product malfunction.

• Brand Name: PHILIPS HOME NEBULIZER
• 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: 21998899
• Report Number: 2518422-2025-105461
• Device Sequence Number: 13132620
• Product Code: CAF
• UDI-Device Identifier: 06946159503020
• UDI-Public: (01)06946159503020(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031413
• 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
• Report Date (Section B): 04/28/2026

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: 1130530
• Device Catalogue Number: 1130530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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