BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION

    MDR report key: 21155037 · Received January 14, 2025

    Report

    Report Number
    2518422-2025-100617
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 24, 2024
    Report Date
    November 5, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424104
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM PARTICLES OR DEGRADATION. THE DEVICE WAS SCRAPPED. THIS RECORD HAS BEEN IDENTIFIED AS A DUPLICATE COMPLAINT OF (B)(4). (B)(4) WILL BE CLOSED AS A DUPLICATE TO (B)(4). FOR REPORTING PURPOSES, PLEASE REFER TO THIS REPORT 2518422-2024-103056.

    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. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM PARTICLES OR DEGRADATION. THE DEVICE WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486488 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX400H11 00606959424104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown