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

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

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

Event Type  malfunction  

Event Description

Patient said the device rattles and her treatment times do take longer.Sn (b)(4).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) 2015 to present.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): PHILLIPS RESPIRONICS
• MDR Report Key: 7384648
• MDR Text Key: 104069315
• Report Number: MW5076214
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1