BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION

    MDR report key: 12134785 · Received July 6, 2021

    Report

    Report Number
    MW5102334
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 2, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A USER OF THE PHILLIPS DREAMSTATION C-PAP MACHINE AND WAS TOLD BY PHILLIPS TO DISCONTINUE USE OF THE MACHINE AND NOT GIVEN ANY DIRECTION AS FAR AS WHAT TO DO UNTIL THE SITUATION WAS CORRECTED. THIS IS A THERAPY STARTED 8 YEARS AGO BY PRESCRIPTION FROM MY PULMONARY DR. TO HELP ME SLEEP THROUGH THE NIGHT. THIS IS LIKE SOMEONE TAKING AWAY YOUR WHEELCHAIR AND TELLING YOU THERE IS NOTHING THEY CAN SUBSTITUTE FOR YOU. I HAVE LOST MANY NIGHTS OF SLEEP DUE TO THIS RECALL. PLEASE HELP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021016 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR AMLODIPINE| ELIQUIS| FLOUXETINE| HYDROCHLOROTHIAZIDE| LISINOPRIL