BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP PRO

    MDR report key: 861121 · Received May 31, 2007

    Report

    Report Number
    MW5002450
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 31, 2007
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A CPAP PRO MASK MADE BY STEVENSON INDUSTRIES INC. THE PROBLEM I AM HAVING IS THE AIR HOSES KEEP BREAKING DURING SLEEP. I HAVE HAD FOUR HOSES BREAK IN THE PAST THREE MONTHS. I HAVE CONTACTED STEVENSON INDUSTRIES AND THEIR RESPONSE IS THEY WILL REPLACE THE HOSES. THERE IS AN OBVIOUS DESIGN FLAW, I HAVE USED OTHER MASKS FOR OVER A YEAR WITH NO BREAKING HOSES. I FEEL THIS IS A VERY SERIOUS PROBLEM AS I DON'T LIKE TO WAKE UP, DO TO NOT BREATHING, IT'S NOT FUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP PRO CPAP PRO NHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other