MAUDE Adverse Event Report: KING SYSTEMS KING VISION; RIGIF LARYNGOSCOPE

Model Number KVL03

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 11/20/2013

Event Type  malfunction  

Event Description

Emergency medical technician attempting to intubate trauma victim using the king vision product.Patient was in respiratory arrest and cardiac arrest, immobilized on a c-spine board and had copious blood in the throat and mouth area.Attempted to use king vision in a standard mid-line approach but was unable to do so due to patient head position in relation to chest, so attempted lateral approach and broke 2 blades.

Manufacturer Narrative

Discussion with emt confirmed that the break in both of the kv blades were located at the proximal end of the blade in an area of thick plastic.The crack was a lateral crack across the blade.The king vision blades have been designed and tested to ensure that fracture under normal use would not occur and to conform to the existing laryngoscope standard (iso 737:2009e) for blade strength.The 150n (34 lb) blade strength requirement has built-in safety margin above any clinically reported forces, and the king vision blades exceed the requirement, measuring well above 160n.A review of the complaint database does not indicate any similar complaints from this product family.

• Brand Name: KING VISION
• Type of Device: RIGIF LARYNGOSCOPE
• Manufacturer (Section D): KING SYSTEMS; noblesville IN
• Manufacturer Contact: wayne nethercutt ; 15011 herriman blvd.; noblesville, IN 46060 ; 3177763175
• MDR Report Key: 3835006
• MDR Text Key: 4453487
• Report Number: 1824226-2014-00001
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KVL03
• Device Catalogue Number: KVL03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 91