MAUDE Adverse Event Report: PHILIPS RESPIRONICS/RESPIRONICS, INC. I-NEB AAD SYSTEM 20MCG/ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 85-149

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Pt states that ventavis device is malfunctioning since it doesn't beep like it used to.Pt is worried that medication is not being delivered and requests new device.No other information known.Did the reported product fault occur while in use with a patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available to be returned for investigation? yes.Did we replace device? yes.No serial number for i-neb provided.Reported to (b)(6) by: patient/caregiver.Dose or amount: 5mcg, frequency: 6 times daily, route: inh.Dates of use: from (b)(6) 2014 to current.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM 20MCG/ML
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS RESPIRONICS/RESPIRONICS, INC.
• MDR Report Key: 7995113
• MDR Text Key: 124962515
• Report Number: MW5080748
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2018

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: 10/22/2018
• 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