BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 21821541 · Received April 10, 2025

    Report

    Report Number
    8021997-2025-000001
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    October 19, 2022
    Report Date
    April 29, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    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 8021997 AND THE 510K NUMBER WAS SELECTED AS K091319 WHICH IS INCORRECT. THE CORRECT CFN NUMBER AND 510K NUMBER SHOULD BE 2518422 AND K131982, WHICH HAS BEEN CORRECTED IN THIS FOLLOW-UP 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
    989755 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown