BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 23345315 · Received October 21, 2025

    Report

    Report Number
    2518422-2025-049887
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    January 30, 2024
    Report Date
    May 28, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959075634
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INADVERTENTLY CAPTURED IN BOX H: IF FOLLOW-UP, WHAT TYPE AS REQUIRED AND DEVICE EVALUATION, IT SHOULD BE NOT APPLICABLE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO A DS2ADV AUTO CPAP WITH AN ALLEGATION OF DS2 MACHINE IS NOT WORKING PROPERLY. IT IS BARELY BLOWING OUT ANY AIR. THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THERE IS NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. THERE WAS ONE ERROR CODE FOUND. DURING THE INVESTIGATION, OBSERVED INLET/OUTLET SEAL WITH CONTAMINATION, BLOWER BOX WITH CONTAMINATION AND ISO PORT WITH CONTAMINATION. THE CUSTOMER COMPLAINT WAS REPRODUCED. THE DEVICE WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122393 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C 00606959075634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown