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

Device Problem Output Problem (3005)

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

Event Date 08/07/2018

Event Type  malfunction  

Event Description

During order placement, pt stated his i-neb has i-neb aad inhalation system was not working properly.He stated the replacement device he was just sent does not beep during treatments.He stated he has not missed any treatments / doses.The device's serial number is (b)(4).The pt was sent a replacement i-neb inhalation device overnight and will send back the malfunctioning device once a return box is received.Dose or amount: 5mcg, frequency: six to nine times daily, route: inhalation.Dates of use: from (b)(6) 2016 to ongoing.Diagnosis or reason for use: i27.0, primary pulmonary hypertension.

• Brand Name: I-NEB AAD INHALATION SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 7837075
• MDR Text Key: 119028130
• Report Number: MW5079509
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR