MAUDE Adverse Event Report: PHILLIPS RESPIRONICS I-NEB AAD SYSTEM

Model Number 85149

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2016

Event Type  malfunction  

Event Description

Per pt, i-neb was beeping with error code 66 during every treatment today.Pt tried new plastics, tilting i-neb to adjust for the right angle but all attempts failed.No lack of treatment reported.No injury was reported.(b)(6) rn was contacted to contact pt to further assist.Pt had the i-neb to be returned for investigation.New i-neb was shipped to pt.Dose or amount: 20mcg/ml, frequency: 6 treatments daily, route: inh.Dates of use: (b)(6) 2016 to ongoing.Reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: I-NEB AAD SYSTEM
• Manufacturer (Section D): PHILLIPS RESPIRONICS
• MDR Report Key: 5969678
• MDR Text Key: 55465616
• Report Number: MW5064932
• 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: 08/09/2016

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
• Device Model Number: 85149
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR