BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCOURAGE DEVICE

    MDR report key: 24713718 · Received March 30, 2026

    Report

    Report Number
    3004961434-2026-00003
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 12, 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 DEVICE IS NOT TURNING ON, SPARKED WHEN THE PATIENT TRIED TO OPERATE. RETURNING THE DEVICE AND POWER CORD FOR QUALITY INSPECTION, NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147286 INCOURAGE DEVICE PERCUSSOR BYI RESPIRATORY TECHNOLOGIES, INC ICS-1M-US 16616 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1