MAUDE Adverse Event Report: I-NEB DEVICE

Device Problem Failure to Charge (1085)

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

Event Type  malfunction  

Event Description

Patient informed the pharmacy that her i-neb machine was not charging even though she has tried multiple outlets at home.Serial number is (b)(4).She has not missed any doses of ventavis due to the device still having enough charge currently.Pharmacy will ship out a new device to patient.Dates of use: from (b)(6) 2017 to current.Diagnosis or reason for use: i27.0.

• Brand Name: I-NEB DEVICE
• Type of Device: I-NEB DEVICE
• MDR Report Key: 6515635
• MDR Text Key: 73609220
• Report Number: MW5069264
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FREQUENCY: 6 TIMES DAILY. ROUTE: INHALATION. ; VENTAVIS. DOSE OR AMOUNT: 5 MCG.