BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINX SLEEP MACHINE

    MDR report key: 6785132 · Received August 8, 2017

    Report

    Report Number
    MW5071483
    Event Type
    Injury
    Date Received
    August 8, 2017
    Date of Event
    April 1, 2017
    Report Date
    August 8, 2017
    Manufacturer
    APNICURE
    Product Code
    OZR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE THE WINX SLEEP MACHINE FOR MY SLEEP APNEA. THE WINX SYSTEM UTILIZES SURGICAL TUBING IN ITS SYSTEM. WHILE THE MANUFACTURER STATES THAT THE TUBING SHOULD BE RINSED WITH A MINIMAL AMOUNT OF WARM WATER AND THE CONTROL UNIT ON A WEEKLY BASIS FOR CLEANING PURPOSES, I AM CONCERNED THAT THERE IS BIOFILM CONTAMINATION POSSIBLE IN BOTH THE UNIT AND TUBING. I HAVE HAD SEVERAL BRONCHIAL INFECTIONS IN THE PAST 6 MONTHS THAT COULD POSSIBLY HAVE SOME RELATIONSHIP TO CLEANING PROTOCOLS. WHEN I REQUESTED INFORMATION REGARDING THE EFFICACY OF THE CURRENT CLEANING PROTOCOL FROM THE MANUFACTURER OF THE WINX SLEEP MACHINE I HAVE BEEN BASICALLY IGNORED. I HAVE ASKED THEM IF IT WAS POSSIBLE TO USE A ON THE SHELF DISINFECTING SOLUTION. I WAS TOLD FINALLY THAT IT WAS OKAY BUT IF THERE WERE ANY PROBLEMS WITH THE MACHINE MY WARRANTY WAS VOID. I ASKED IF THERE WERE APPROVED OR RECOMMENDED DISINFECTANTS AND WAS TOLD THERE WERE NONE. ASKED FOR MANY TIMES BUT NEVER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553617 WINX SLEEP MACHINE WINX OZR APNICURE ONLY ONE MODEL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention