MAUDE Adverse Event Report: CAREFUSION LIMB-O-SINGLE LIMB; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number AGNX204X

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

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

Event Date 06/22/2016

Event Type  malfunction  

Event Description

The anesthesiologist used laryngeal mask airway (lma) connected to circuit and could not properly ventilate the patient.The humidivent was partially occluded, and there was more water than usual.The sponge was partially occluding.Airway changed from lma to endotracheal tube (et)and switched anesthesia faulty circuit.The patient's oxygen saturations were fine and was discharged post procedure as anticipated.

• Brand Name: LIMB-O-SINGLE LIMB
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5916961
• MDR Text Key: 53662992
• Report Number: 5916961
• Device Sequence Number: 1
• Product Code: CAI
• 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: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/07/2015
• Device Model Number: AGNX204X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR