BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 12908403 · Received December 1, 2021

    Report

    Report Number
    3004961434-2021-00008
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    February 25, 2020
    Report Date
    December 1, 2021
    Manufacturer
    RESPIRATORY TECHNOLOGIES INC.
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED THE PATIENT'S DEFIBRILLATOR TO DISCHARGE WHILE USING THE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER FOUND NO ISSUES WITH THE DEVICE. THE MANUFACTURER FOUND THE DEVICE TO BE CONTAMINATED WITH A LIQUID. THE DEVICE WAS SCRAPPED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808774 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES INC. 500055-000 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other