BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAM STATION AUTO CPAP

    MDR report key: 12216901 · Received July 22, 2021

    Report

    Report Number
    MW5102722
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    July 20, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE A PHILLIPS CPAP DREAMSTATION FOR PAST 6 YEARS. I STARTED USING A SOCLEAN2 OZONE CPAP CLEANING MACHINE ON (B)(6) 2020. BEGINNING IN (B)(6) 2021 I HAVE HAD A BAD COUGH, DIZZINESS, HEADACHE, SOMETIMES DIFFICULTY BREATHING. I WENT TO MY DOCTOR SEVERAL TIMES, RECEIVED PRESCRIPTION FOR COUGH MEDS. I ALSO SEE A SLEEP DOCTOR WHO DID NOT ADVISE ME OF A PROBLEM. HE HAD PRESCRIBED THE CPAP. IN (B)(6) 2021 I RECEIVED A NOTICE FROM PHILLIPS THAT THE OZONE MACHINE MAY BE MAKING SOUND INSULATION DEGRADE AND CAUSING GASES AND PARTICLES TO GET INTO THE CPAP AND MY LUNGS. I HAVE BEEN NOTICING BLACK SPECS FLOATING IN THE HUMIDIFIER TANK AND ALSO SOME ON BOTTOM CORNERS IN THE WATER. THIS HAS BEEN SEEN SINCE ABOUT (B)(6). MY SLEEP DOCTOR NEVER WARNED ME OF ANY PROBLEM. I DID TELL HIM ABOUT THE COUGH AND THE BLACK SPECS WHICH I ASSUMED WAS EITHER MILDEW OR DIRT. I HAVE CLEANED THE MACHINE AND HUMIDIFIER TANK AT LEAST ONCE A WEEK. I EXPECT TO GET AN APPOINTMENT TO SEE MY SLEEP DOCTOR WITHIN ABOUT A WEEK AND REQUEST APPROPRIATE TESTS. I STOPPED USING THE CPAP AND SOCLEAN2 MACHINES IMMEDIATELY ON (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112563 DREAM STATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC. DSX 500 S11

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability