BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 835285 · Received April 2, 2007

    Report

    Report Number
    MW1042444
    Event Type
    Other
    Date Received
    April 2, 2007
    Date of Event
    March 11, 2007
    Report Date
    April 2, 2007
    Manufacturer
    *
    Product Code
    NHJ
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS SCHEDULED FOR A SLEEP STUDY. AFTER MY ELECTRODES HAD BEEN ATTACHED, THE TECHNICIAN ARRIVED TO EXPLAIN HOW THE TUBING WOULD BE CONNECTED TO MY MASK. I ASKED HIM IF HE COULD SHOW ME THE BACTERIA FILTER WHICH WOULD BE PLACED IN-LINE BETWEEN THE CPAP MACHINE AND THE TUBING TO MY MASK. THE TECHNICIAN SAID HE DID NOT HAVE ONE AND WENT TO SPEAK WITH HIS SUPERVISOR AND SUPPLY. HE RETURNED TEN MINUTES LATER AND SAID NEITHER HIS SUPERVISOR OR SUPPLY HAD ANY BACTERIA FILTERS. THIS WAS IN SPITE OF THE FACT THAT THEIR CPAPS WERE USED BY HUNDREDS OF PTS. MOST IMPORTANT WAS THE STICKER ON THE FRONT OF THE CPAP MACHINE THAT WARNED "IF THIS MACHINE IS USED ON MULTIPLE PTS A BACTERIA FILTER MUST BE USED." I LEFT THE CLINIC FOR FORTY MINUTES TO TRAVEL TO MY HOME TO RETRIEVE A BACTERIA FILTER FROM MY HOME. I HAD THE FILTERS BECAUSE I SOMETIMES HAVE TO RENT CPAP MACHINES. REPRESENTATIVES OF RESPIRONICS HAVE ADVISED ME TO USE BACTERIA FILTERS WHEN I USE ANY MACHINE WHICH HAS BEEN USED BY ANOTHER PERSON. THE SLEEP DISORDERS CLINIC AND DR WERE UNAWARE OF THE NEED TO USE BACTERIA FILTERS. IT WOULD BE ADVISABLE THAT THE CLINIC BE REQUIRED TO PROVIDE NOTICE TO THEIR PTS ABOUT THEIR POSSIBLE EXPOSURE TO BACTERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other