MAUDE Adverse Event Report: AEROGEN LTD. AERONEB PROFESSIONAL SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Failure to Deliver (2338)

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

Event Date 12/28/2019

Event Type  malfunction  

Event Description

Arrived in patient room for treatment, discovered approximately 2ml of fluid in aerogen medication cup (aerogen # lpch 64202).Fluid withdrawn from medication cup.Tested aerogen with normal saline, aerogen's lights shut off and stopped misting within 10 seconds of being turned on.All cables, wires, looked fine.Aerogen red flagged and removed from service.New aerogen installed in patient's room, medication treatment delivered without further event.

• Brand Name: AERONEB PROFESSIONAL SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.; galway business park; dangan galway
• MDR Report Key: 9643443
• MDR Text Key: 176851030
• Report Number: 9643443
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 330 DA