FDA Adverse Event Malfunction Summary report: N

LIFEVAC USA

MDR report key: 23224095 · Received October 6, 2025

Report

Report Number
MW5176967
Event Type
Malfunction
Date Received
October 6, 2025
Date of Event
September 30, 2025
Report Date
October 2, 2025
Manufacturer
LIFEVAC, INC.
Product Code
GCX
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

LIFEVAC IS A SUCTION DEVICE INTENDED TO AID A CHOKING VICTIM. FDA HAS PUBLISHED GUIDANCE ABOUT THESE DEVICES HERE HTTPS://WWW.FDA.GOV/MEDICAL-DEVICES/SAFETY-COMMUNICATIONS/FDA-ENCOURAGES-PUBLIC-FOLLOW-ESTABLISHED-CHOKING-RESCUE-PROTOCOLS-FDA-SAFETY-COMMUNICATION?MIBEXTID=XFXF2I, BUT I DON'T THINK THIS IS ADEQUATE. LIFEVAC HAMMERS FB ALL DAY LONG WITH THEIR PROMISES AND DRAMA, BUT WHEN CHALLENGED DIRECTLY THEY SAY, "ALTHOUGH WE DO ALWAYS SUGGEST USING LIFEVAC AFTER ALL OTHER CHOKING PROCEDURES HAVE BEEN ADMINISTERED, LIFEVAC IS NOT DANGEROUS TO USE AS IT IS A NON-INVASIVE AIR-WAY CLEARANCE DEVICE." THE PROBLEM IS THEY DON'T. I AM CONCERNED THAT PEOPLE ARE BEING MISLEAD AND WILL ATTEMPT TO USE THE ANTI CHOKING DEVICE AS A FIRST MEASURE, POTENTIALLY PUTTING THE VICTIM AT FURTHER RISK. BASED ON THEIR PUBLISHED INFO, HERE ARE SOME POTENTIALLY INVALID CLAIMS LIFEVAC MAKES. (IN WRITING) CLINICALLY PROVEN: SAFE & EFFECTIVE (DID THEY DO A CLINICAL TRIAL?) (IN WRITING) WORKS ON BOTH CHILDREN & ADULTS (CHILDREN AND ADULTS HAVE DIFFERENT PHYSICAL PHYSIOLOGY, DOES THE DEVICE WORK FOR BOTH?) (IN WRITING) PRODUCT NEVER EXPIRES (HAVE THEY DONE SHELF-LIFE TESTING? EVERYTHING HAS AN EXPIRY, ESPECIALLY PLASTIC DUE TO OXIDATION.) (VIDEO) 3023+ LIVES SAVED THERE IS NO MENTION OF RISKS ANYWHERE. UNKNOWN. LIFEVAC CLAIMS TO BE CLINICALLY TESTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1868610 LIFEVAC USA APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX LIFEVAC, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown