MAUDE Adverse Event Report: INEB

Device Problems Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)

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

Event Date 03/30/2017

Event Type  malfunction  

Event Description

Patient reports that her ineb is giving her treatments, but it does not turn off like it used to, sn# (b)(4) she never gets a smiley face."it is just not acting right" no increase in pah symptoms and she feels she is still getting the medication, sending out a new device.Dates of use: from (b)(6) 2013 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: INEB
• Type of Device: INEB
• MDR Report Key: 6485672
• MDR Text Key: 72673883
• Report Number: MW5069045
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR