BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 19337862 · Received May 16, 2024

    Report

    Report Number
    2518422-2024-29012
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    October 9, 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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE 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 OF EYE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, HYPERSENSITIVITY, NAUSEA / VOMITING, ASTHMA (NEW OR WORSENING) INFLAMMATORY RESPONSE. OTHER RESPIRATORY ISSUES, RESPIRATORY FAILURE, & ACUTE RESPIRATORY DISTRESS SYSTEM (ARDS). 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
    744083 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other