MAUDE Adverse Event Report: PHILIPS VENTRAVIS I-NEB SYSTEM

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 12/07/2017

Event Type  malfunction  

Event Description

Pt states her ventavis i-neb is not working properly.It is not spraying the medication as it should, when she is done with her treatments the chamber is almost full.She gets no error codes on the screen, she has been cleaning everything.Has new meshes and nothing is working.It has been like this for about 2 weeks, she feels she is getting some benefit from each treatment but not the max benefit.She did not have the i-neb with her, but per one track the s/n is (b)(4).Dose or amount: 5 mcg.Frequency: six times a day.Route: inhalation.Dates of use: (b)(6) 2013 to present.Diagnosis or reason for use: i270 primary pulmonary hypertension.

• Brand Name: VENTRAVIS I-NEB SYSTEM
• Type of Device: VENTRAVIS I-NEB SYSTEM
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 7154417
• MDR Text Key: 96209522
• Report Number: MW5074291
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/06/2022
• 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: 71 YR