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

Model Number 1083220

Device Problems Overheating of Device (1437); Failure to Shut Off (2939)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information alleging a faulty i-nebulizer event occurred.The patient states the device would not end treatment and that the device was heating up.The patient confirmed that they were not receiving their full promixin dose.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: I-NEB CF
• Type of Device: 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18397054
• MDR Text Key: 331393834
• Report Number: 2518422-2023-37912
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730000909
• UDI-Public: 00383730000909
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1083220
• Device Catalogue Number: 1083220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1