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

Lot Number 2011IN210355

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 08/02/2016

Event Type  malfunction  

Event Description

Device malfunction, error 22.Could not clear malfunction with troubleshooting.Sn not available at time of report.Sent new i-neb and gold disc kit for pt to continue treatments.Reported in event entry form on (b)(6) 2016 am.Did the reported product fault occur while in use with a pt? yes.Did the product issue cause or contribute to pt or clinical injury? no.If yes, was any medical intervention provided? please explain.Is the actual device available to be returned for investigation? pt has the device in her possession.Dose or amount: 5mcg, frequency: 6-9 times daily, route: inh.Dates of use: from first ship (b)(6) 2012 to continuing.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: I-NEB
• Manufacturer (Section D): PHILIPS RESPIRONICS ; city field way ; tangmere, chichester PO20 2FT; UK PO20 2FT
• MDR Report Key: 5969825
• MDR Text Key: 55466029
• Report Number: MW5064950
• 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: 08/02/2016

1 Device was Involved in the Event

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: Lay User/Patient
• Device Expiration Date: 04/13/2017
• Device Lot Number: 2011IN210355
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR