BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION CPAP

    MDR report key: 19256117 · Received May 6, 2024

    Report

    Report Number
    2518422-2024-25637
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    October 2, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    CORRECTIONS HAVE BEEN MADE AS FOLLOWS: BECOME AWARE DATE CHANGED FROM 10/12/2023 TO 10/02/2023. DUE DATE CHANGED FROM 11/11/2023 TO 11/01/2023. SECTION B: EVENT DATE - CHANGED FROM 10/12/2023 TO 10/02/2023. SECTION G: DATE RECEIVED BY MFG - CHANGED FROM 10/12/2023 TO 10/02/2023.

    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 CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING ASTHMA (NEW OR WORSENING) AND REDUCED CARDIOPULMONARY RESERVE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642702 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX200H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other