BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 20276811 · Received September 23, 2024

    Report

    Report Number
    2518422-2024-59281
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    October 9, 2023
    Report Date
    September 23, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959051515
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    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 EYE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, NAUSEA, VOMITING, ASTHMA (NEW OR WORSENING), INFLAMMATORY RESPONSE, KIDNEY DISEASE OR TOXICITY, LUNG DISEASE, OTHER (UNSPECIFIED EVENT), RESPIRATORY FAILURE, LUNG DAMAGE, KIDNEY DAMAGE, RESPIRATORY ISSUES, REACTIVE AIRWAY DISEASE (RAD), AND ACUTE RESPIRATORY DISTRESS SYSTEM (ARDS). 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
    1430350 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C 00606959051515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other