BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAM STATION

    MDR report key: 14874634 · Received June 29, 2022

    Report

    Report Number
    MW5110617
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AE, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A (B)(6) IS MY CLAIM NUMBER WITH PHILLIPS REGARDING THE RECALL OF MY CPAP MACHINE. I'M NOT ABLE TO USE IT AND THEY HAVE NOT REPLACED IT. I'M WORRIED I AM GOING TO HAVE A STROKE. I EITHER WANT IT REPLACED OR WANT A REFUND TO BUY A NEW MACHINE. I'VE GAINED WEIGHT AND MY BLOOD PRESSURE IS UP DUE TO LACK OF SLEEP FOR ALMOST A YEAR NOW. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422918 DREAM STATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female