BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 18882452 · Received March 11, 2024

    Report

    Report Number
    2518422-2024-13379
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 13, 2024
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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
    1221192 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRATORY TECHNOLOGIES, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown