MAUDE Adverse Event Report: CAREFUSION AIRLIFE; ADULT MANUAL RESUSCITATOR

Model Number 2K8017

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

There was a broken plastic piece found from inside the blue bag.

• Brand Name: AIRLIFE
• Type of Device: ADULT MANUAL RESUSCITATOR
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 3943287
• MDR Text Key: 4640129
• Report Number: 3943287
• Device Sequence Number: 1
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 2K8017
• Device Catalogue Number: 2K8017
• Device Lot Number: 0000646101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES