MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. I-NEB AAD SYSTEM; PHILIPS I-NEB

Model Number 85-149

Device Problems Material Integrity Problem (2978); Output Problem (3005)

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

Event Date 07/13/2018

Event Type  malfunction  

Event Description

Spouse states that there is plenty of meds after treatment and is worried pt is not being administered medication via device.Pt does not report change in symptoms.Sn (b)(4), device being replaced.They have a back up device.No return box sent.No other info known.Dose or amount: 5mcg, frequency six times daily, 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: PHILIPS I-NEB
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 7738846
• MDR Text Key: 115796309
• Report Number: MW5078716
• 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: 07/13/2018

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: 07/31/2018
• 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
• Patient Age: 84 YR