MAUDE Adverse Event Report: PHILIPS RESPIRONICS - UK I-NEB AAD

Device Problem Application Program Problem (2880)

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

Event Date 07/22/2016

Event Type  malfunction  

Event Description

Pt states the i-neb device she uses for ventavis rarely gives the signal that she is done, maybe 1 out of 10 times.She eventually stops the treatment because she gets tired.I gave all the numbers she could find on the device.She thinks she is still getting her full dose of medication and has not had any side effects or symptoms.We are replacing this device.We are sending a return box for the broken device.Pt aware.Dates of use: (b)(6) 2013 to current.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD
• Type of Device: I-NEB
• Manufacturer (Section D): PHILIPS RESPIRONICS - UK
• MDR Report Key: 5969749
• MDR Text Key: 55466400
• Report Number: MW5064945
• Device Sequence Number: 2
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR