MAUDE Adverse Event Report: PHILIPS I-NEB AAB SYSTEM

Device Problems Failure to Deliver (2338); Device Operates Differently Than Expected (2913)

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

Event Date 03/18/2016

Event Type  malfunction  

Event Description

Patient informed she is having issues with the ventavis device.Machine is not giving her any error and it reports vibrating and whirling but she is not receiving any indication that she is receiving medication.A nurse was sent to her home to review machine and treatment completion.Dose or amount: 1 inhalation; frequency: 6-9 times/day; route: inhaled.Dates of use: (b)(6) 2013 to current; diagnosis or reason for use: i27.0.

• Brand Name: I-NEB AAB SYSTEM
• Type of Device: I-NEB AAB SYSTEM
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 5525701
• MDR Text Key: 41248117
• Report Number: MW5061241
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/21/2016

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR