BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 2

    MDR report key: 16683895 · Received April 4, 2023

    Report

    Report Number
    MW5116345
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 22, 2023
    Report Date
    March 31, 2023
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A REPLACEMENT DREAMSTATION2 RECENTLY. I USED IT BRIEFLY UNTIL MY RESMED UNIT WAS DELIVERED. DURING THIS TIME THE HEATED TUBE (SMALLER DIAMETER) THAT CAME WITH THE MACHINE DISCONNECTED FROM THE BASE OF THE COUPLER THAT ATTACHES TO THE MASK INTAKE. IT GRADUALLY WORKED LESS. I DON'T KNOW IF THIS IS BY DESIGN. I'VE BEEN USING CPAP <10 YRS AND NEVER HAD THE COUPLING SEPARATE IN THIS LOCATION. I SUFFERED NO INJURY. JUST PICKED UP THE LOOSE END IN THE MIDDLE OF NIGHT AND REATTACHED. MY CONCERN IS FOR ANYONE WHO ABSOLUTELY NEED A PROPER FUNCTIONING TUBE. IT IS CURIOUS ALSO THAT THE COUPLING THAT ATTACHES TO THE MASK INTAKE IS SO TIGHT THAT I HAD TO STRUGGLE TO REMOVE IT WHEN I SWITCHED MACHINES. I'M GLAD I NO LONGER HAVE TO DEAL WITH THE PHILLIPS SAGA. DON'T WANT TO BE BOTHERED ABOUT IT. IF YOU ARE INTERESTED CHECK IT OUT ON YOUR END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416090 DREAMSTATION 2 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male