BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 1 CPAP MACHINE

    MDR report key: 12137362 · Received July 7, 2021

    Report

    Report Number
    MW5102377
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Report Date
    July 5, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'VE BEEN USING THE DREAMSTATION 1 CPAP MACHINE. NO ONE HAS BOTHERED TO REACH OUT AND NOTIFY ME OR OTHERS OF THE SO CALLED RECALL ON THESE MACHINES WHICH IS CAUSING NUMEROUS ISSUES IN PEOPLE. NOTHING IS EVEN CURRENTLY BEING DONE FAST ENOUGH TO RECTIFY THIS SITUATION EITHER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023011 DREAMSTATION 1 CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR