MAUDE Adverse Event Report: RESPIRONICS, INC. I-NEB; NEBULIZER, (DIRECT PATIENT INTERFACE)

Model Number R1080086

Device Problem Output Problem (3005)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

The manufacturer became aware of a user of an i-neb ph nebulizer alleging the device reportedly took more than 30 minutes to complete the nebulization of the medication.The patient reported he/she was able to complete the treatment although it took longer than usual.There was no patient harm or injury reported.No medical intervention was required.No product is returning for investigation.There was no patient harm or injury.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device has not been returned to the manufacturer.

• Brand Name: I-NEB
• Type of Device: 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17756864
• MDR Text Key: 323530174
• Report Number: 2518422-2023-23187
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• 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: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R1080086
• Device Catalogue Number: R1080086
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1