BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVAC HOME KIT

    MDR report key: 16409910 · Received February 21, 2023

    Report

    Report Number
    3011053282-2022-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    June 17, 2022
    Report Date
    December 5, 2022
    Manufacturer
    LIFEVAC LLC
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AN ANONYMOUS REPORTER WHO IS NOT A PATIENT OR A DEVICE USER FILED A VOLUNTARY MEDWATCH REPORT # MW5110917. THIS REPORTER USED A DESCRIPTION OF A CHOCKING INCIDENT FROM THE DEVICE MANUFACTURER LIFEVAC'S WEBSITE AS SUBMITTED BY THE CHOKING CHILD'S MOTHER. THE ANONYMOUS REPORTER STATED THE DEVICE CAUSED A STUCK LOLLIPOP TO SHATTER AND COULD POSSIBLY CAUSE AN INJURY. WHAT WAS LEFT OUT FROM THIS REPORT WAS THE MOST IMPORTANT PART OF THE INCIDENT. THE FACT THAT THE DEVICE WAS ABLE TO DISLODGE A LOLLIPOP FROM A CHILD'S BLOCKED AIRWAYS AND ALLOWED THE CHILD TO BREATHE. THE CHILD'S MOTHER ATTESTED TO THE FACT THAT THE DEVICE SAVED HER CHILD AND REMOVED THE OBSTRUCTION. THE DEVICE HAS BEEN USED IN OVER 500 INCIDENCES OF AIRWAY OBSTRUCTION AND HAS WORKED AS INTENDED EACH TIME TO REMOVE AN AIRWAY BLOCKAGE. THERE HAS NEVER BEEN A REPORT OF PRODUCT FAILURE OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644161 LIFEVAC HOME KIT SUCTION APPARATUS GCX LIFEVAC LLC LVC3001 220625

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male