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

Model Number	1130531
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information a philips home nebulizer was not working correctly.The device is does work but medication will not come out.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 previously received information a philips home nebulizer was not working correctly.The device is does work, but medication will not come out.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.This notification was initiated for review related to a philips home nebulizer device where customer stated that device was not working and the medicine would not come out.No death, serious harm or injury was reported.Analysis of past events do not indicate an adverse event allegation or would be likely to occur if the product allegation was to recur.In addition, a review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.This event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious in/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: 22637563
• Report Number: 2518422-2025-108323
• Device Sequence Number: 8155145
• Product Code: CAF
• UDI-Device Identifier: 06946159503037
• UDI-Public: (01)06946159503037(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): 06/02/2026

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: 1130531
• Device Catalogue Number: 1130531
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 06/02/2026
• 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