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

Model Number AG-PX1050-US

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

Aerogen nebulizer was half full of veletri and no alarm was going off on pump.Nurse visually saw this and corrected problem by knocking against hand and pump immediately started working again.Informed doctor of issue and they were concerned that they had no alarm going off and had to rely on visually looking at device to see if it works properly.Doctor requested policy & procedure on pump to review.No harm to patient.

• Brand Name: AEROGEN SOLO NEBULIZATION SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LIMITED; rene van de zande; 2500 bee cave road building 1, suite 300; austin TX 78746
• MDR Report Key: 6913441
• MDR Text Key: 88156504
• Report Number: 6913441
• 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: 09/25/2017,09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: AG-PX1050-US
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO