BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAM STATION 2 AUTO CPAP ADVANCED

    MDR report key: 17690979 · Received September 5, 2023

    Report

    Report Number
    MW5145182
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 29, 2023
    Manufacturer
    PHILLIPS/RESPIRONICS, INC
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CONTINUED PROBLEMS WITH FUNCTION OF MACHINE SINCE (B)(6) 2022. ADVENT HEALTH RESPIRATORY REFUSED TO SERVICE THE PRODUCT OR RETURN TO MANUFACTURER. HUMIDIFIER, POWER SWITCH, AND VARIABLE PRESSURE ARE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379225 DREAM STATION 2 AUTO CPAP ADVANCED VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS/RESPIRONICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male