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

Model Number 85-149

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Pt reports having prolonged treatments with "no smiley face" and stated "i spoke with pharmacy and they told me i could stop after 5 mins." she is currently using 20 mcg gold disc for treatments.I advised her to make sure she is sitting upright with the device at a 90 degrees angle, make sure inhalations are for at least 3 seconds, so more medication could be delivered and that lips are sealed over mouth piece.I also advised her to continue the treatments a couple mins longer than 5 mins to see if the device will go off on its own.She reports doing treatments as described and states that when a new device was sent previously her treatment times were normal, and she had a smiley face.Mrs (b)(6) would like to know if another i-neb could be delivered.No adverse effect reported due to device malfunction.Replacement device will be delivered to pt.(i-neb device sn (b)(4)).No other info provided.Dose or amount: 5mcg, frequency: 6 times/day, route: inh.Dates of use: from (b)(6) 2013 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: 7230555
• MDR Text Key: 98787797
• Report Number: MW5074983
• 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: 01/26/2018

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
• Device Model Number: 85-149
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2018
• 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