MAUDE Adverse Event Report: KING SYSTEMS KING LTS-D KIT; OROPHARYNGEAL AIRWAY

Model Number KLTSD431

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/05/2019

Event Type  Death  

Manufacturer Narrative

At the time of this report, the only information available is contained within fda's maude report number (b)(4), the end user did not file a complaint with king systems.If more information becomes available king systems will review it accordingly.King systems became aware of this event through a review of fda's maude website.King systems has no record of recieving a medwatch report from fda for this event.This event was reported under ambu inc.And not king systems.With the limited information available through the report, and no device available for evaluation, it appears that the device may have malfunctioned.King systems is reporting this event although it is not clear that the potential malfunction of the device caused or contributed to a death.

Event Description

As described in medwatch (b)(4): "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 KIT
• Type of Device: OROPHARYNGEAL AIRWAY
• Manufacturer (Section D): KING SYSTEMS; 15011 herriman blvd.; noblesville, in
• Manufacturer (Section G): VBM MEDIZINTECHNIK GMBH; einsteinstrasse 1; sulz a.n, D-721 72; GM D-72172
• Manufacturer Contact: steven fox ; 15011 herriman blvd.; noblesville, in
• MDR Report Key: 10867631
• MDR Text Key: 217100811
• Report Number: 1824226-2020-00002
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• PMA/PMN Number: K033186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/19/2020

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 Model Number: KLTSD431
• Device Catalogue Number: KLTSD431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death