BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO BIPAP

    MDR report key: 20046978 · Received August 23, 2024

    Report

    Report Number
    2518422-2024-52977
    Event Type
    Death
    Date Received
    August 23, 2024
    Date of Event
    July 3, 2023
    Report Date
    August 22, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959429772
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF REP DREAMSTATION AUTO BIPAP 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
    1313132 REP DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX700S11F 00606959429772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death