BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO

    MDR report key: 19232039 · Received May 2, 2024

    Report

    Report Number
    2518422-2024-24379
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    October 12, 2023
    Report Date
    July 5, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTING COUNTRY WAS ADDED TO BOX E, INITIAL REPORTER.

    Additional Manufacturer Narrative · 0

    MDR REPORT 2518422-2024-24379 AND 2518422-2024-24379-1 ARE DUPLICATE OF MDR REPORT 2518422-2024-25480. MDR REPORT 2518422-2024-24379 AND 2518422-2024-24379-1 WERE FILED FOR THE SAME ISSUE REPORTED ON MDR REPORT 2518422-2024-25480.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED.

    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 LUNG DISEASE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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
    841887 DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR), BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other