MAUDE Adverse Event Report: RESPIRONICS, INC. HOME NEB 120V60HZ; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	1130530
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device has not been returned to the manufacturer.
Event or Problem Description
The manufacturer became aware of allegations that a home neb 120v60hz showing smoke from the device.In addition, the patient reported smell possibly due to overheating of the device.There was no report of patient harm or injury.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information becoming aware of the allegations that a home neb 120v60hz showing smoke from the device.In addition, the patient reported smell possibly due to overheating of the device.There was no report of patient harm or injury.**udi related data quality updates only** previously section d2, d4 and g4 were incorrectly reported.In this report, the following sections have been corrected.Section e1 have been updated with additional information.

• Brand Name: HOME NEB 120V60HZ
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18171115
• Report Number: 2518422-2023-30642
• Device Sequence Number: 4144747
• Product Code: CAF
• UDI-Device Identifier: 06946159503020
• UDI-Public: (01)06946159503020
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2019
• 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 Age: 3 YR
• Patient Sex: Female