MAUDE Adverse Event Report: I NEB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Pt's daughter reports that for the past month, the i neb machine for ventavis at times turns off in the middle of treatments.It also takes awhile to start the treatment, they confirmed that the machine is charged even when they have these issues.A new i neb is being sent to replace the machine.The i neb's serial number is (b)(4).These events occur while in use with the pt; however, no harm to the pt has occurred because of this.Dose or amount: 20 mcg, frequency: 6 times/day, route: inhaled.Dates of use: (b)(6) 2013 to present.Diagnosis or reason for use: pah.

• Brand Name: I NEB
• Type of Device: I NEB
• MDR Report Key: 5962943
• MDR Text Key: 55226375
• Report Number: MW5064852
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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