MAUDE Adverse Event Report: AEROGEN LTD AERONEB PROX; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number PROX

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2016

Event Type  malfunction  

Event Description

Noted medication was building up in the nebulizer and not being nebulized to the patient.There was approximately 4-6ml of liquid in the nebulizer; estimated patient was not receiving the flolan for approximately 30-45 minutes, based on flolan syringe pump set at 8ml/hour.No harm to patient.

• Brand Name: AERONEB PROX
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD; 816 congress avenue; suite 1400; austin, TX 78701
• MDR Report Key: 5871203
• MDR Text Key: 51975948
• Report Number: 5871203
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PROX
• Device Lot Number: AP-1405592
• Other Device ID Number: CLINICAL ENGINEERING #0000059
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR