BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 2

    MDR report key: 19352521 · Received May 17, 2024

    Report

    Report Number
    MW5155113
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 15, 2024
    Manufacturer
    PHILLIPS/RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE SLEEP APNEA AND AM PRESCRIBED BY MY SLEEP DOCTOR TO USE A CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MACHINE. MY PHILLIPS DREAM STATION 2 CPAP MACHINE IS DEFECTING. I HAD A MEETING WITH MY SLEEP DOCTOR AND TOLD HER ABOUT IT AND SHE MENTIONED THAT THIS IS A POTENTIAL MANUFACTURE'S DEFECT WITH THE HEATING PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502128 DREAMSTATION 2 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS/RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male