BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AUTO BIPAP

    MDR report key: 19850047 · Received July 29, 2024

    Report

    Report Number
    2518422-2024-47760
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    October 9, 2023
    Report Date
    July 29, 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

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN END USER DEVELOPED A KIDNEY DISEASE/TOXICITY; CANCER. WHILE USING AN REP DREAMSTATION AUTO BIPAP, DOM. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369774 REP DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX700S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other