MAUDE Adverse Event Report: AEROGEN COMPANY AERONEB PRO-X; NEBULIZER

Model Number UNAVAILABLE

Device Problem Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 06/27/2017

Event Type  Injury  

Event Description

Product stopped delivering the continuous nebulization of epoprostenol for unknown reason.Dose or amount: 40ng/kg/min nitric oxide, frequency: continuous, route: inhalation.Dates of use:(b)(6) 2017.Diagnosis or reason for use: pulmonary hypertension.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: AERONEB PRO-X
• Type of Device: NEBULIZER
• Manufacturer (Section D): AEROGEN COMPANY
• MDR Report Key: 6771121
• MDR Text Key: 82046745
• Report Number: MW5071397
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 21