MAUDE Adverse Event Report: RESPIRONICS I-NEB DEVICE

Model Number INEB

Device Problem Break (1069)

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

Event Date 05/27/2016

Event Type  malfunction  

Event Description

Pt stated that the bottom plastic base that holds the top of ineb is broken and she's holding it together with a rubberband.She said this happened last time too and she had the device replaced in the past and was requesting a new device.She said she's able to do her treatment but wants a replacement device.Serial number (b)(4).Lot number from shipment from 07/07/2015: 2014in201447.Dose or amount: 20 mcg/ml.Frequency: daily.Route: inhaled.Dates of use: from (b)(6) 2014 to ongoing.Reason for use: pah.Acetellon.

• Brand Name: I-NEB DEVICE
• Type of Device: I-NEB DEVICE
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 5771898
• MDR Text Key: 48863083
• Report Number: MW5063233
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2016
• Device Model Number: INEB
• Device Lot Number: 2014IN201447
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR