MAUDE Adverse Event Report: AEROGEN, LTD. /EMERGO GROUP, INC. AERONEB PRO-X; NEBULIZER

Model Number 06-AG-PX1000-US

Device Problems Disconnection (1171); Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 02/02/2015

Event Type  malfunction  

Event Description

Electrical plug disconnects from adapter causing loss of electrical source (power) and therefore loss of therapy (medication delivery) unknowingly.Aerogen does not sound an alarm, simply has a yellow indicator light with an ! to indicate loss of power.

• Brand Name: AERONEB PRO-X
• Type of Device: NEBULIZER
• Manufacturer (Section D): AEROGEN, LTD. /EMERGO GROUP, INC.; 816 congress avenue; suite 1400; austin TX 78701
• MDR Report Key: 4736854
• MDR Text Key: 5889452
• Report Number: 4736854
• Device Sequence Number: 2
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/27/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 06-AG-PX1000-US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1