MAUDE Adverse Event Report: CAREFUSION AIRLIFE; ADULT MANUAL RESUSCITATOR; VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK

Catalog Number 2K8017

Device Problems Break (1069); No Flow (2991)

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

Event Date 05/04/2016

Event Type  malfunction  

Event Description

During a cardiac event it was noted by rt managing the airway that the bag resuscitator did not have oxygen flow out when bag was manually squeezed.It appears the valve at the distal end of the equipment was broken or defective.When the product was switched out there were no further airway management issues.

• Brand Name: AIRLIFE
• Type of Device: ADULT MANUAL RESUSCITATOR; VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5705596
• MDR Text Key: 46804444
• Report Number: 5705596
• Device Sequence Number: 1
• 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: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 2K8017
• Device Lot Number: 0000859202
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2016
• 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
• Patient Age: 69 YR
• Patient Weight: 71