MAUDE Adverse Event Report: RESPIRONICS, INC. I-NEB SYSTEM (NEBULIZER) 20 MCG/ML; NEBULIZER / DIRECT PATIENT INTERFACE

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Sn: (b)(4) - pt called to report that when doing a treatment.It is taking longer than 5-6 minutes (that is usually the time taking her and this just started a couple days ago).She reports it is sometimes taking 10 minutes or more.Confirmed with patient that she is cleaning her meshes daily and boiling them weekly.She reports meshes were replaced with last shipment, so should not need to be replaced.Had patient check her mouthpiece to look inside and see if valve is okay.Will replace device.Device error occurred while in use with pt.Error did not lead to injury.Dose or amount : 20mcg/ml; frequency: 6x/day; route: inh; dates of use: from (b)(6) 2018 to current; diagnosis or reason for use: pah.

• Brand Name: I-NEB SYSTEM (NEBULIZER) 20 MCG/ML
• Type of Device: NEBULIZER / DIRECT PATIENT INTERFACE
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 8169395
• MDR Text Key: 130786533
• Report Number: MW5082161
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1