BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO CPAP

    MDR report key: 19354465 · Received May 20, 2024

    Report

    Report Number
    2518422-2024-29684
    Event Type
    Death
    Date Received
    May 20, 2024
    Date of Event
    May 12, 2023
    Report Date
    November 18, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ON REP DREAMSTATION AUTO CPAP DEVICE ALLEGING PATIENT PASSED AWAY. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT MDR 2518422-2024-29684 IS A NON-REPORTABLE COMPLAINT WHICH HAS BEEN UPDATED/CORRECTED IN THIS FOLLOW UP REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ON REP DREAMSTATION AUTO CPAP DEVICE ALLEGING PATIENT PASSED AWAY. 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
    1452514 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death