MAUDE Adverse Event Report: PHILIPS I-NEB AAD SYSTEM; NEBULIZER, DIRECT PATIENT INTERFACE

Model Number I-NEB

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/07/2018

Event Type  Injury  

Event Description

Dr.(b)(6) reporting that they believe there is something wrong with patients ventavis device.Patient presented to hospital for sob and the patient added her treatment times over the past week have gradually been increasing.Closer to 10 min or more.Patient was admitted.In addition patient says her device is about 5 years old.Advised we would be sending a new device by courier.Patient was sent return box for malfunctioning pump.No other information available.Dose or amount: ventavis 6 treatments per day.Frequency: every 4 hours.Route: inh.Dates of use: (b)(6) 2017 to present.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: NEBULIZER, DIRECT PATIENT INTERFACE
• Manufacturer (Section D): PHILIPS; new york NY
• MDR Report Key: 7193611
• MDR Text Key: 97534014
• Report Number: MW5074560
• 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: 01/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: I-NEB
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR