BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION ST30

    MDR report key: 18620963 · Received February 1, 2024

    Report

    Report Number
    2518422-2024-05408
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    December 5, 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
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    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 SINUS ISSUES, BREATHING ISSUES, COUGHING, LUNG ISSUES. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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
    385742 REP DREAMSTATION ST30 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX1030S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other