BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 23404915 · Received October 28, 2025

    Report

    Report Number
    3004961434-2025-00001
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 1, 2025
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORTS ARE ON FILE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    RESPIRTECH RECEIVED A REPORT FROM THE PATIENT'S MOTHER STATING THAT THE DEVICE "BURST" AND THAT A FIRE OCCURRED AT THE RESIDENCE. AN INVESTIGATION WAS CONDUCTED BY THE LOCAL FIRE DEPARTMENT. ACCORDING TO THE OFFICIAL FIRE INVESTIGATION REPORT, THE FIRE ORIGINATED ON OR NEAR THE BED ON THE EAST WALL OF THE TRAILER. THE INVESTIGATOR WAS UNABLE TO RULE OUT EITHER THE ELECTRICAL CORD TO THE DEVICE TO THE INCOURAGE DEVICE OR A CANDLE LOCATED ON THE DESK AS POTENTIAL SOURCES. BASED ON THE EVIDENCE AND SCENE CONDITIONS, THE FIRE WAS CLASSIFIED AS ACCIDENTAL. AT THIS TIME, THERE IS NO CONCLUSIVE EVIDENCE IDENTIFYING THE DEVICE AS THE DEFINITIVE CAUSE OF THE FIRE. RESPIRTECH WILL CONTINUE TO MONITOR FOR ANY ADDITIONAL INFORMATION THAT MAY BECOME AVAILABLE.

    Description of Event or Problem · 0

    RESPIRTECH RECEIVED A REPORT FROM THE PATIENT'S MOTHER STATING THAT THE DEVICE "BURST" AND THAT A FIRE OCCURRED AT THE RESIDENCE. AN INVESTIGATION WAS CONDUCTED BY THE LOCAL FIRE DEPARTMENT. ACCORDING TO THE OFFICIAL FIRE INVESTIGATION REPORT, THE FIRE ORIGINATED ON OR NEAR THE BED ON THE EAST WALL OF THE TRAILER. THE INVESTIGATOR WAS UNABLE TO RULE OUT EITHER THE ELECTRICAL CORD TO THE DEVICE TO THE INCOURAGE DEVICE OR A CANDLE LOCATED ON THE DESK AS POTENTIAL SOURCES. BASED ON THE EVIDENCE AND SCENE CONDITIONS, THE FIRE WAS CLASSIFIED AS ACCIDENTAL. AT THIS TIME, THERE IS NO CONCLUSIVE EVIDENCE IDENTIFYING THE DEVICE AS THE DEFINITIVE CAUSE OF THE FIRE. RESPIRTECH WILL CONTINUE TO MONITOR FOR ANY ADDITIONAL INFORMATION THAT MAY BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218340 INCOURAGE DEVICE PERCUSSOR BYI RESPIRATORY TECHNOLOGIES, INC ICS-1M-US 16011 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening