MAUDE Adverse Event Report: I NEB

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

Patient reports that for the last week her i neb, sn (b)(4), has been beeping with the error code 66.She confirmed she is holding the i neb at a 90 degree angle.She confessed that there are times that she bends down and is aware that is incorrect but she has been diligent lately about holding it at the right angle.Regardless, every treatment for about the past week, the machine has been beeping error 66.She is only recovering partial treatments about half or less than half the time.She usually just stops doing the treatments after several minutes when the machine will not stop beeping and giving the error code 66.States that, out of the treatments she is able to complete, her treatment times are much longer.Sending a new i neb machine to arrive to her tomorrow.She is aware that she should call us if she has any issues with the new machine.Dose or amount: 20 mcg/ml.Frequency: 5 times/day.Route: inhaled.Dates of use: from (b)(6) 2012 to present.Diagnosis or reason for use: pah.

• Brand Name: I NEB
• Type of Device: I NEB
• MDR Report Key: 6209262
• MDR Text Key: 63612859
• Report Number: MW5066941
• 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: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1