BEUDAMED
    FDA Adverse Event Other Summary report: N

    DREAMSTATION 1 AUTO CPAP

    MDR report key: 18463507 · Received January 5, 2024

    Report

    Report Number
    MW5149874
    Event Type
    Other
    Date Received
    January 5, 2024
    Date of Event
    December 30, 2023
    Report Date
    January 3, 2024
    Manufacturer
    PHILIPS/RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HELLO. MY PHILLIPS DREAMSTATION CPAP WAS PART OF THE RECALL PROGRAM. I REGISTERED MY DEVICE, RECEIVED A REMANUFACTURED ONE THROUGH THE RECALL PROGRAM, AND USED THIS MACHINE UNTIL THIS PAST WEEKEND. I HAVE NEVER USED AN OZONE CLEANER ON EITHER DEVICE, BUT I REGULARLY WASHED THE CLEANABLE PARTS BY HAND WITH SOAP AND WATER. THE LAST WEEK OF DECEMBER I HAD BAD HEADACHES FOR SEVERAL MORNINGS IN A ROW; WHEN I OPENED THE CPAP RESERVOIR TO CHECK THE WATER LEVEL, I NOTICED BLACK SPOTS AROUND THE TUBING CONNECTOR AS WELL AS THE RESERVOIR COVER. THIS HAD NEVER OCCURRED BEFORE, AND I HAVE IMMEDIATELY STOPPED USING THIS MACHINE. I WANTED YOU TO KNOW BECAUSE THE REMANUFACTURED CPAP WAS SUPPOSED TO BE "SAFE." I HOPE I DO NOT HAVE LONGTERM REPERCUSSIONS FROM USING THIS MACHINE, AS I CAN'T KNOW HOW LONG IT WAS EMITTING HARMFUL FUMES AND/OR PARTICLES. I AM WORKING WITH MY INSURANCE TO GET A NEW DEVICE. I CAN SEND PHOTOS IF THAT WOULD BE HELPFUL. REFERENCE REPORT: #MW5149875.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002066 DREAMSTATION 1 AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS/RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female AMLODIPINE 5MG.| CALCIUM.| CPAP.| ESTRADIOL VAGINAL MCG.| MULTIVITAMIN.| VITAMIN C.