MAUDE Adverse Event Report: AES AES; LMA

Catalog Number 10636050

Device Problems Disconnection (1171); Difficult to Remove (1528)

Patient Problems Cyanosis (1798); Extubate (2402)

Event Date 12/23/2013

Event Type  Injury  

Event Description

Surgery was over and anesthesiologist was waking the pt up by calling his name while attempting to pull out the lma.The tube became disconnected from the laryngeal mask.The laryngeal mask was stuck in the airway.Two anesthesiologists worked as a team using a forceps to retrieve the mask.At one point the pt was dusky/blue and had a thready pulse.After mask was removed the pt re-intubate, his vital stabilized and he recovered and was discharged within 2.5 hours.

• Brand Name: AES
• Type of Device: LMA
• Manufacturer (Section D): AES
• MDR Report Key: 3573253
• MDR Text Key: 4035048
• Report Number: MW5033813
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10636050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 112