BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION BIPAP

    MDR report key: 19492001 · Received June 7, 2024

    Report

    Report Number
    2518422-2024-34902
    Event Type
    Death
    Date Received
    June 7, 2024
    Date of Event
    November 21, 2022
    Report Date
    June 7, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    K131982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A DREAMSTATION AUTO CPAP DEVICE HAD PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE MANUFACTURER WAS CONTACTED REGARDING THE DEATH OF THE PATIENT AND THE CUSTOMER WILL BE RETURNING THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031196 REP DREAMSTATION BIPAP ENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX900S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death