BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION BIPAP AUTOSV

    MDR report key: 20109204 · Received August 30, 2024

    Report

    Report Number
    2518422-2024-55234
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    October 9, 2023
    Report Date
    August 30, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM UNO LEGAL LITIGATION IN REFERENCE TO A REP DREAMSTATION BIPAP AUTOSV WITH ALLEGATIONS OF KIDNEY CANCER, EYE IRRITATION, NOSE IRRITATION AND SKIN IRRITATION. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THIS DEVICE IS NOT PART OF THE RECALL. 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
    1766002 REP DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other