MAUDE Adverse Event Report: RING SYSTEMS CORP. KING LT-D LARYNGEAL TUBE

Model Number KLTD204

Device Problem Kinked (1339)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 04/23/2016

Event Type  Death  

Event Description

Patient in cardiac arrest.Ring airway inserted during resuscitation attempt.Resuscitation attempt unsuccessful and patient pronounced.Autopsy report indicates the tube was kinked (bent in half) in patient's airway.

• Brand Name: KING LT-D LARYNGEAL TUBE
• Type of Device: KING LT-D LARYNGEAL TUBE
• Manufacturer (Section D): RING SYSTEMS CORP.; 15011 herriman blvd. ; noblesville IN 46060
• MDR Report Key: 5658695
• MDR Text Key: 45376410
• Report Number: MW5062263
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KLTD204
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR