MAUDE Adverse Event Report: KING SYSTEMS CORPORATION KING LT SYSTEMS; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number KING TUBE #4

Device Problems Output Problem (3005); Material Split, Cut or Torn (4008)

Patient Problem Cardiac Arrest (1762)

Event Date 12/23/2021

Event Description

On (b)(6) 2021 around 0530 the hospital ems was dispatched to the residence of (b)(6) female found by family member in cardiac arrest, cpr already in progress.Upon arrival, ems inserted a #4 king lt, but a seal could not be obtained for bvm ventilations.Upon removal of the king tube, it was recognized that both balloons had tears in them.Fda safety report id# (b)(4).

Event Description

Additional information received for report # mw5106315 on: 05/05/2022, to correct name and address and procode to: cae.

• Brand Name: KING LT SYSTEMS
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): KING SYSTEMS CORPORATION
• MDR Report Key: 13111029
• MDR Text Key: 282996635
• Report Number: MW5106315
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: KING TUBE #4
• Device Lot Number: 1000500013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White