MAUDE Adverse Event Report: CAREFUSION 221, INC. AIRLIFE AEROSOL BOTTLE; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number ZI-0314001

Device Problems Device Inoperable (1663); No Flow (2991)

Patient Problem No Information (3190)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

The equipment started to malfunction and stopped producing set amount of oxygen while hooked to flowmeter.We switched equipment to another flowmeter and problem persisted, finally changed out equipment and patient improved.

• Brand Name: AIRLIFE AEROSOL BOTTLE
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION 221, INC.; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 4705982
• MDR Text Key: 5651447
• Report Number: 4705982
• Device Sequence Number: 1
• 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: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: ZI-0314001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2015
• Patient Sequence Number: 1
• Patient Age: 78 YR