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

Model Number 85-149

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 05/30/2018

Event Type  malfunction  

Event Description

Patient's ventavis device is still working, but it now whistles loud when she inhales.Sn (b)(4).Sending patient a replacement device.Device malfunction.Did the reported product fault occur while in use with a patient: yes.Did the product issue cause or contribute to patient or clinical injury: no.Is the actual device available to be returned for investigation: yes.Did we replace device: yes.Dates of use: (b)(6) 2013 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: I-NEB
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 7586533
• MDR Text Key: 110754478
• Report Number: MW5077730
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 85-149
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR