MAUDE Adverse Event Report: AMBU INC. KING LTS-D LARYNGEAL TUBE; KING AIRWAY

Model Number KLTSD431

Device Problem Break (1069)

Patient Problem Death (1802)

Event Date 03/05/2019

Event Type  Death  

Event Description

Medica crew initially attempted intubation which was unsuccessful, this was followed with airway management using a king laryngeal tube.After insertion of the king airway, the tube broke at the hub where the bag-valve mask would have attached.

• Brand Name: KING LTS-D LARYNGEAL TUBE
• Type of Device: KING AIRWAY
• Manufacturer (Section D): AMBU INC. ; columbia MD
• MDR Report Key: 8617025
• MDR Text Key: 145357159
• Report Number: 8617025
• Device Sequence Number: 1
• Product Code: CAE
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/03/2019

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: No Information
• Device Model Number: KLTSD431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2019
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Weight: 10