BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AUTO

    MDR report key: 21178227 · Received January 17, 2025

    Report

    Report Number
    2518422-2025-004295
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    October 12, 2023
    Report Date
    January 17, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959429765
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    "THE MANUFACTURER RECEIVED INFORMATION OF A REP DREAMSTATION AUTO CPAP ALLEGING NOSE IRRITATION, HYPERSENSITIVITY, INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, LUNG DISEASE. 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
    1086353 REP DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F 00606959429765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other