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

Model Number R1080086

Device Problem No Device Output (1435)

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 would not nebulize the medication at all.The user cleaned the device in the correct way, there was no change.The unit still would not nebulize the medication.The patient had another unit (same model) and this one 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.The i-neb was returned to the manufacturer for investigation, but due to the patient's lease being up on the device, the repair was cancelled.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 : the lease was up on product for the patient, evaluation was cancelled.

• 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: 17746879
• MDR Text Key: 323422046
• Report Number: 2518422-2023-22976
• 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

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1