BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION CPAP

    MDR report key: 12832504 · Received November 17, 2021

    Report

    Report Number
    2518422-2021-06847
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 14, 2025
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    UDI-DI
    00606959026575
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON MAY 05, 2025, AND SECTION H11 SHOULD BE REPORTED AS: THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ATRIAL FIBRILLATION AND VISUALIZATION OF PARTICLES RELATED TO CPAP DEVICE'S SOUND ABATEMENT FOAM. THE SECTIONS B1, B2, H1, H6 HAVE BEEN CORRECTED IN THIS REPORT AS FOLLOWS: SECTION B1 WAS CORRECTED FOR ADVERSE EVENT AND PRODUCT PROBLEM. (ONLY THE PRODUCT PROBLEM WAS CHECKED IN THE PREVIOUS MDR.). SECTION B2 WAS CORRECTED TO OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. (PREVIOUSLY, IT WAS BLANK.). SECTION H1 WAS CHANGED FROM MALFUNCTION TO SERIOUS INJURY. SECTION H6 HAS BEEN CORRECTED AND UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728942 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC CAX400T12 00606959026575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other