BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 11878266 · Received May 25, 2021

    Report

    Report Number
    3004961434-2021-00002
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    January 28, 2021
    Report Date
    May 26, 2021
    Manufacturer
    RESPIRATORY TECHNOLOGIES INC.
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ENCOURAGE DEVICE ALLEGEDLY CAUSED A HEART CONDITION. THE PATIENT IS CURRENTLY WEARING A HEART MONITOR AND CONTINUES TO RECEIVE VEST THERAPY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED THIS EVENT TO THE FDA ON 02/24/2021 UNDER AN INCORRECT MANUFACTURER REPORT NUMBER, 3004961343-2021-00002. THE CORRECT MANUFACTURER REPORT NUMBER IS 3004961434-2021-00002.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING VEST THERAPY WITH AN INCOURAGE DEVICE CAUSED A HEART CONDITION. THE PATIENT IS CURRENTLY WEARING A HEART MONITOR AND CONTINUES TO RECEIVE VEST THERAPY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775987 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES INC. R500055-000 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other