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

Model Number	1083220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging to an issue related to i-neb cf.The patient was died.The device was returned to manufacturer for evaluation, technician confirmed that the device visually looked fine.Treatments were finishing in full.The device was scrapped.

• Brand Name: I-NEB CF
• Common Device Name: NEBULIZER
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19832436
• Report Number: 2518422-2024-47200
• Device Sequence Number: 15329599
• Product Code: CAF
• UDI-Device Identifier: 00383730000909
• UDI-Public: 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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: Lay User/Patient
• 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: 05/30/2023
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2014
• 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