BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 18892912 · Received March 13, 2024

    Report

    Report Number
    2518422-2024-13649
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    January 8, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : THE DEVICE HAS YET TO BE 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 VISUALIZATION OF PARTICLES IN THE AIR PATH. THE PATIENT ALLEGES THIS DEVICE HAD LED TO DAMAGE TO THE LUNGS AND FEAR OF SECONDARY DISEASES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED AS REQUIRED BY THE PATIENT. THE ACTION IS PENDING BEFORE THE PRINCELY DISTRICT COURT OF LICHTENSTEIN. THERE IS NO CONFIRMED INFORMATION ON THE WHEREABOUTS OF THE DEVICE, BUT IT IS ASSUMED THAT THE PLAINTIFF IS KEEPING THE DEVICE FOR A FORENSIC EXAMINATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212667 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. EUX500S15

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown