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

Model Number R1080086

Device Problem Improper Flow or Infusion (2954)

Patient Problem Pneumothorax (2012)

Event Date 04/01/2023

Event Type  Injury  

Event Description

The manufacturer received information alleging it took longer (over 20 minutes) to do inhaling and pneumothorax developed.The patient was admitted to the hospital due to not being able to breathe easily due to the amount of time it took to do inhaling.The symptom receded on (b)(6) 2023.The patient said she was not hospitalized due to the nebulizer, but the patient requested that the device be replaced with a new one.Device not returned to manufacturer.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 not returned to 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: 18615400
• MDR Text Key: 334219490
• Report Number: 2518422-2024-05272
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female