MAUDE Adverse Event Report: RESPIRONICS, INC. I-NEB CF UK UNIT; NEBULIZER

Model Number	1083220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer became aware of an allegation of i-neb cf uk unit alleges death - patient no longer using ineb device.There is no allegation of serious or permanent harm or injury.There was no report of medical intervention.No additional information can be requested at this time.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 with an i-neb cf uk unit device has passed away.There was no allegation that the device contributed to the death.The device was returned as no longer needed and was scrapped without testing.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.In this report, box d, g, h has been corrected.

• Brand Name: I-NEB CF UK UNIT
• Common Device Name: NEBULIZER
• 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: 21688986
• Report Number: 2518422-2025-038523
• Device Sequence Number: 18355339
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 1083220
• Device Catalogue Number: 1083220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2018
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown