MAUDE Adverse Event Report: PHILIPS/RESPIONICS I-NEB DEVICE; NEBULIZER

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Pt says mouthpiece on i-neb device is loose and comes off too easily.Replacement unit being sent.Pt has not experienced any adverse event due to product problem.Manufacturer: bayer.Dose or amount: 5mcg, frequency: 8 times daily, route: inh.Dates of use: from (b)(6) 2012 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: I-NEB DEVICE
• Type of Device: NEBULIZER
• Manufacturer (Section D): PHILIPS/RESPIONICS
• MDR Report Key: 6692703
• MDR Text Key: 79521500
• Report Number: MW5070829
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• 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