MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. I-NEB NEBULIZER ; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

Pt is requesting an i-neb replacement device because he is having a problem with long treatment times (more than 30 mins each treatment) with current device (sn #(b)(4)).Confirmed with pt that he is using distilled water to clean parts daily and boil parts weekly.No adverse effect reported.We are shipping a replacement device.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.Is the actual device available to be returned for investigation? yes.Did we replace the device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: I-NEB NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 9317799
• MDR Text Key: 166746163
• Report Number: MW5091062
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Patient Sequence Number: 1