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

Model Number KLTSD434

Device Problem Use of Device Problem (1670)

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 01/12/2023

Event Type  Death  

Manufacturer Narrative

Kltsd434 device sample from the affected lot (1000509082) were returned by the customer for evaluation.After careful examination of the sample, it was determined that there was sufficient visual evidence indicating that the device had been used on a patient but there were no visual signs of damage to the tube or any of the other components of the device.Functional testing of the device revealed a small opening in the proximal cuff of the device.The location and asymmetric structure of the opening is consistent with a perforation of the cuff potentially caused by a sharp object, such as patients' sharp teeth.This is supported by the fact that the devices are 100% inspected as part of the manufacturing process to ensure no leaks are present in the cuffs and the end user confirmation that it is their crews' standard practice to check the device prior to use, as directed in the ifu that accompanies the product, making it highly unlikely for the reported failure to have occurred prior to use of the device.No visible damage was observed on the distal cuff of the sample, isolating the failure to the proximal cuff.Based on the results of the investigation conducted, we can conclude that there is not sufficient evidence to indicate that reported failure resulted from a design or manufacturing failure; therefore, the cause of the reported failure can most likely be attributed to a defect occurring during the use of the device.Although it cannot be confirmed that the reported hypoxia experienced by the patient was a cause of or contributed to the death, king systems has decided to report this event.The customer reported an additional similar situation as part of the complaint, but there was no indication that the patient went without an airway or showed signs of hypoxia after a simple airway was used.

Event Description

On 01/24/2023 king systems received a customer complaint report related to product kltsd434 ambu / king ltsd, size 4,w/suction port, non-sterile kit.The reported failure was "not sealing - per customer: some error by user, but also signs of product failure of not sealing".The event took place on (b)(6) 2023 and king systems awareness date of the event was 01/13/2023.The paramedics were responding to a call for a patient in cardiac arrest.The patient was pronounced dead at the scene.It was reported that the patient went without an airway for several minutes during the airway attempts resulting in some hypoxia.The patient was ventilated through alternate airway management procedures.It cannot be confirmed that hypoxia was a cause of death since the patient had several comorbidities.

• Brand Name: KING LTS-D KIT
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): KING SYSTEMS CORPORATION; 15011 herriman blvd.; noblesville IN 46060
• Manufacturer (Section G): VBM MEDIZINTECHNIK GMBH; 1, einsteinstrasse; sulz am neckar; baden-wurttemberg 72172 ; GM 72172
• Manufacturer Contact: wen gao ; 15011 herriman blvd.; noblesville, IN 46060 ; 3177765172
• MDR Report Key: 16359752
• MDR Text Key: 309371425
• Report Number: 1824226-2023-00001
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2023

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?: No
• Device Expiration Date: 09/08/2023
• Device Model Number: KLTSD434
• Device Catalogue Number: KLTSD434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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 Outcome(s): Death