BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE SYSTEM

    MDR report key: 10460886 · Received August 27, 2020

    Report

    Report Number
    3004961434-2020-00001
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 30, 2020
    Report Date
    January 15, 2021
    Manufacturer
    RESPIRATORY TECHNOLOGIES INC.
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN INCOURAGE VEST THERAPY INTERFERED WITH A PATIENTS PACEMAKER. THE ISSUE WAS NOTED BY THE PATIENT'S CARDIOLOGIST. THERE WAS NO INFORMATION RECEIVED TO INDICATE SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS FOUND TO OPERATE AS DESIGNED AND PASSED ALL TESTING.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE VEST THERAPY INTERFERED WITH A PATIENT'S PACEMAKER. THE ISSUE WAS NOTED BY THE PATIENT'S CARDIOLOGIST. 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
    923613 INCOURAGE SYSTEM PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES INC. R500055-000 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other