BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCOURAGE DEVICE

    MDR report key: 24637711 · Received March 19, 2026

    Report

    Report Number
    3004961434-2026-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 23, 2026
    Report Date
    May 21, 2026
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT STATES DEVICE HAS BURNED TERMINALS WHERE CORD PLUGS IN THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124583 INCOURAGE DEVICE PERCUSSOR BYI RESPIRATORY TECHNOLOGIES, INC ICS-1M-US M1019122022 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1