MAUDE Adverse Event Report: PHILIPS RESPIRONICS I-NEB AAD SYSTEM

Model Number 86-149

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

Pt reported that her chamber may have gotten 'warped' the last time she boiled her parts because the medication is leaking out of the chamber.She said this started about a week ago after boiling the parts so she requested that we send new mesh and chamber for this shipment.Pt reported she had the parts in the boiling water pretty long and was inquiring how long they need to be boiled for, informed pt that they should be boiled for about 6-10 minutes.Pt reported that it was probably longer than the.No other info provided.Strength/dose or amount: 20mcg/ml, frequency: qid, route: inh.Dates of use: from (b)(6) 2012 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: I-NEB
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 7742804
• MDR Text Key: 115965900
• Report Number: MW5078795
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 86-149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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