BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP W/HUMID CELL/BT

    MDR report key: 22812980 · Received August 14, 2025

    Report

    Report Number
    2518422-2025-109141
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 7, 2025
    Report Date
    March 3, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062733
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS NOTIFICATION WAS PREVIOUSLY REPORTED ON BEHALF OF A USER OF A DS2ADV AUTO CPAP W/HUMID CELL/BT DEVICE WITH ALLEGATION(S) THAT THE POWER BOX ON THE CORD IS GETTING EXTREMELY HOT AND THE MACHINE TURNS OFF. THE PATIENT REPORTS WAKING UP WITH A STUFFY NOSE. CORRECTION TO H1 TO REFLECT PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE POWER BOX ON THE CORD OF A DS2ADV AUTO CPAP W/HUMID CELL/BT DEVICE IS GETTING EXTREMELY HOT AND THE MACHINE TURNS OFF. THERE WAS NO SMOKE, FLAMES, MELTING, WARPING OR VOIDS/GAPS IN THE ENCLOSURE. THE POWER SUPPLY WAS PLUGGED INTO A POWER STRIP. THE PATIENT REPORTS WAKING UP WITH A STUFFY NOSE. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629849 DS2ADV AUTO CPAP W/HUMID CELL/BT VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C 00606959062733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown