MAUDE Adverse Event Report: CAREFUSION CORPORATION AIRLIFE; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number 2K8805

Device Problem Difficult to Remove (1528)

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

Event Date 03/09/2017

Event Type  malfunction  

Event Description

Patient was being bag/mask ventilated; once endotracheal tube placed, attempted to remove mask from the resuscitation bag and the mask was unable to be removed from the resuscitation bag.

• Brand Name: AIRLIFE
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): CAREFUSION CORPORATION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 6442159
• MDR Text Key: 71119333
• Report Number: 6442159
• Device Sequence Number: 0
• Product Code: BTM
• 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: 03/17/2017,03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/02/2021
• Device Model Number: 2K8805
• Device Catalogue Number: 2K8005
• Device Lot Number: 0001030580
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2017
• 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: PATIENT WAS BEING INTUBATED, BAG/VALVE MASK BEING