MAUDE Adverse Event Report: RESPIRONICS INEB DEVICE

Device Problem Sticking (1597)

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

Event Date 06/06/2017

Event Type  malfunction  

Event Description

Patient states since yesterday, she is not getting the full treatment each time.She states that she has to suck really hard and maybe will get something.Pt states that it seems as though something might be "stuck".Pt states that just now she opened the device and a lot of medication "smoke" came out that was not coming out when attempting treatment.Pt states that she feels she got 2-3 treatments out of 5 per day the last two days.No change in breathing.Pt states that there are no error codes that appear.Verified with pt that her meshes are clean and don't appear damaged (pt states that she just boiled them).Pt also states that battery is fully charged, sn# (b)(4).Dates of use: (b)(6) 2012 to present.Diagnosis or reason for use: pah.

• Brand Name: INEB DEVICE
• Type of Device: INEB DEVICE
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 6636424
• MDR Text Key: 77534339
• Report Number: MW5070371
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/07/2017

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR