MAUDE Adverse Event Report: KING SYSTEMS CORP KING LARYNGEAL TUBE SIZE 5.0; KING LARYNGEAL AIRWAY

Model Number SIZE 5

Device Problems Bent (1059); Kinked (1339)

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

Event Date 03/01/2015

Event Type  Death  

Event Description

Pt arrested on (b)(6) 2015.Responders initiated resuscitative measures, including insertion of a king airway.Resuscitation attempt was unsuccessful, pt was pronounced, and turned over to medical examiner for posting.Autopsy results revealed airway "kinked" or bent on insertion.Waveform and digital capnography, as well as physical examination of chest rise and breath sounds indicated pt was being adequately ventilated.This is to report potential defect in the airway itself.Diagnosis or reason for use: cardiac arrest.

• Brand Name: KING LARYNGEAL TUBE SIZE 5.0
• Type of Device: KING LARYNGEAL AIRWAY
• Manufacturer (Section D): KING SYSTEMS CORP
• MDR Report Key: 4627466
• MDR Text Key: 21452471
• Report Number: MW5041571
• 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: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIZE 5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 01/27/1