BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO CPAP

    MDR report key: 19852295 · Received July 29, 2024

    Report

    Report Number
    2518422-2024-47783
    Event Type
    Death
    Date Received
    July 29, 2024
    Date of Event
    July 24, 2023
    Report Date
    May 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS RECEIVED. IN THIS REPORT UPDATED AS- THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) AND PIL WAS NOT ABLE TO CONFIRM THE COMPLAINT OR ADDRESS THE SYMPTOMS SPECIFIED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED. SECTION EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, CONCLUSION CODE GRID HAVE BEEN UPDATED/CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF DS2ADV AUTO CPAP THAT THE PATIENT HAS PASSED AWAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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
    897409 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death