BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIN BULLET

    MDR report key: 11364949 · Received February 22, 2021

    Report

    Report Number
    MW5099542
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 18, 2021
    Manufacturer
    3B MEDICAL, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HELLO, I AM A CPAP MACHINE USER AND I HAVE STUMBLED ACROSS A DANGEROUS THIRD PARTY CLEANING MACHINE. I DON'T WANT TO HURT THIS COMPANY BECAUSE THEIR MAIN PRODUCT IS A HUGE BLESSING TO ME. THE PRODUCT IS CALLED THE LUMIN BULLET AND WAS DESIGNED TO CLEAN SLEEP APNEA TUBES WITH UV LIGHT. HOWEVER, WHEN THE INNER "BULLET" IS CHARGED AND SITTING OUTSIDE THE PROTECT CASE - THE MAGNET INSIDE THE DEVICE CAN PULL THE "BULLET" TO THE OUTSIDE OF THE DEVICE AND ACTIVE THE UV LIGHT DIRECTLY EXPOSED. IT HAPPENED ONCE TO ME AND I QUICKLY LOOKED AWAY. FOR A MEDICAL DEVICE COMPANY, THIS SEEMS LIKE A SURPRISING FLAW OF SAFETY AND WELL BEING. IF YOU NEED A CLEARER PICTURE, I CAN EMAIL AGAIN OR SEND A VIDEO. I WILL NEED TO GET SOME UV PROTECTED GLASSES FIRST. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260562 LUMIN BULLET DISINFECTANT, MEDICAL DEVICES LRJ 3B MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR