BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 21609886 · Received March 14, 2025

    Report

    Report Number
    8030978-2025-000001
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 24, 2022
    Report Date
    December 8, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959429765
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUSLY SUBMITTED REPORT, THE CFN NUMBER WAS SELECTED AS 8030978 AND THE 510K NUMBER WAS SELECTED AS K091319 WHICH ARE INCORRECT. THE CORRECT CFN NUMBER AND 510K NUMBER SHOULD BE 2518422 AND K131982, WHICH HAVE BEEN CORRECTED IN THIS FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2022-53624. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAMSTATION AUTO CPAP DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THE PATIENT ALLEGES PARTICLES WERE OBSERVED IN THE WATER TANK OF THE DEVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. 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
    689029 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR BZD RESPIRONICS, INC. UDSX500S11F 00606959429765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown