FDA Adverse Event Death Summary report: N

LIFEVAC

MDR report key: 24563197 · Received March 10, 2026

Report

Report Number
3011053282-2026-00001
Event Type
Death
Date Received
March 10, 2026
Date of Event
February 11, 2026
Report Date
March 10, 2026
Manufacturer
LIFEVAC LLC
Product Code
GCX
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

DURING A SNACK TIME AT SCHOOL, A 3RD GRADE STUDENT CHOKED ON A GRAPE THAT HE HAD BROUGHT FROM HOME. WHEN THE STUDENT BEGAN CHOKING, HE RAN OUT OF THE CLASSROOM. THE TEACHER RAN AFTER THE CHILD, CAUGHT UP WITH HIM AND BEGAN THE LIFESAVING MEASURES. THE TEACHER ATTEMPTED THE HEIMLICH MANEUVER AND CALLED FOR THE SCHOOL NURSE. THE SCHOOL NURSE THEN ASSISTED WITH ABDOMINAL THRUSTS. THE SCHOOL RESOURCE OFFICER ALSO RESPONDED TO ASSIST WITH THE CHOKING RESCUE PROTOCOLS. THEIR EFFORTS WERE UNSUCCESSFUL. THE SCHOOL PERSONNEL CALLED 911 RIGHT AWAY AND THE FIRST RESPONDERS WHO INCLUDED A MEDICAL DOCTOR, A NURSE AND A PARAMEDIC ARRIVED ON THE SCENE. THE FIRST RESPONDERS PERFORMED THE HEIMLICH MANEUVER OVER 100 TIMES BUT WERE NOT ABLE TO REMOVE THE OBSTRUCTION. THE CHILD WAS THEN TRANSPORTED TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD. THE HOSPITAL MEDICAL PERSONNEL STATED THE GRAPE WAS TOO FAR DOWN THE AIRWAY TO BE REMOVED. IT IS NOT EXACTLY KNOWN WHEN THE LIFEVAC DEVICE WAS USED IN THE COURSE OF THE CHOKING RESCUE BUT SUPPOSEDLY, THE DEVICE WAS USED. IT IS KNOWN THE SCHOOL HAD THE LIFEVAC DEVICE ON SITE AS PART OF THE OVERALL EMERGENCY RESPONSE PREPAREDNESS. IN ACCORDANCE WITH THE STATE LAW HB 549 (ALSO KNOWN AS THE WESTYN BRYAN MANDRELL ACT) PASSED IN JUNE 2025, EVERY PUBLIC SCHOOL IN TEXAS IS REQUIRED TO HAVE AT LEAST ONE NON-INVASIVE AIRWAY CLEARANCE DEVICE (E.G., LIFEVAC). THE SCHOOL DISTRICT MANAGEMENT STATED THAT ALL STAFF MEMBERS RECEIVE ANNUAL TRAINING ON HOW TO RESPOND TO CHOKING INCIDENTS AND OTHER MEDICAL EMERGENCIES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
619801 LIFEVAC SUCTION ANTI-CHOKING DEVICE AS A SECOND-LINE TREATMENT GCX LIFEVAC LLC LVC3001

Patients

Seq Age Sex Outcome Treatment
1 7 YR Male Death