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

Model Number 85-149

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

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

Event Date 06/22/2018

Event Type  malfunction  

Event Description

Spoke with pt's wife, she said they are having some trouble with the i-neb device that pt is using ((b)(4)).Once they load the drug in the medication chamber, the device displays code 55 on the screen.This code should only display at the beginning of the treatment.If the medication chamber does not have any medication in it.Also after 1 or 2 minutes, the device shuts off.Advised that we are going to send a replacement device to arrive tomorrow.Also inform her that the malfunctioning device needs to be sent back to (b)(6) for maintenance/repair.She v/u.There were no adverse event due to malfunctioning device.Dose or amount: ventavis 5mcg, frequency: 6 times/day, route: inhaled.Dates of use: from (b)(6) 2018 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 7654521
• MDR Text Key: 113161815
• Report Number: MW5078188
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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
• 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
• Patient Age: 83 YR