BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 19425539 · Received May 30, 2024

    Report

    Report Number
    2518422-2024-32381
    Event Type
    Death
    Date Received
    May 30, 2024
    Date of Event
    October 9, 2023
    Report Date
    October 17, 2025
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT: DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED NEW AND RELEVANT INFORMATION ON 10/03/2025. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED. PIL CONFIRMED NO PRESENCE OF DEGRADED SOUND ABATEMENT FOAM USING A FITT AND THE ASSOCIATED PROCEDURE (B)(4) (V01). SEE (B)(4) (V01) FOR THE PROCEDURE USED TO MAKE THIS DETERMINATION. THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE, WHICH SUGGESTS THAT THE SOURCE OF CONTAMINATION WAS EXTERNAL TO THE DEVICE. SECTION G3 AND H6 HAVE BEEN UPDATED IN THIS FOLLOW UP REPORT.

    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 KIDNEY DISEASE/TOXICITY, LIVER DISEASE/TOXICITY, CANCER AND PANCREAS ISSUES. THE PATIENT HAS BEEN PASSED AWAY. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    1257753 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death