MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN SOLO NEBULIZATION SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number UNKNOWN

Device Problem Break (1069)

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

Event Date 11/01/2017

Event Type  malfunction  

Event Description

Prn (as needed) atrovent given.The next day, medication was found in nebulizer.Nebulizer troubleshot and found to be not working.Nebulizer was not functioning - did not deliver the medication.Was found the next day due to treatment being given only prn.Disposable aerogen solo nebulizer - the lot # is unknown.The package was thrown away.

• Brand Name: AEROGEN SOLO NEBULIZATION SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LIMITED; 2500 bee cave road; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 7406220
• MDR Text Key: 104673616
• Report Number: 7406220
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1