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

Device Problems Break (1069); Component Falling (1105)

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

Event Date 10/24/2016

Event Type  malfunction  

Event Description

Patient reports he dropped his device a couple of weeks ago and a piece on the base broke off and the cap keeps coming off and interrupting his treatments.He is able to complete his treatments if he holds the pieces together.Product fault occurred while patient was using device.Patient did not report any clinical injury.Device will be returned for investigation.Replacement device is being sent to patient.(b)(4).No other information provided.Dose or amount: 5mch.Frequency: 6 times daily.Route: inhaled.Dates of use: from (b)(6) 2012 to current.Diagnosis or reason for use: i27.0.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: I-NEB
• Manufacturer (Section D): PHILLIPS RESPIRONICS
• MDR Report Key: 6124503
• MDR Text Key: 60881838
• Report Number: MW5066271
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR