BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 15457445 · Received September 20, 2022

    Report

    Report Number
    3004961434-2022-00005
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    August 23, 2022
    Report Date
    November 15, 2022
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BYI
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED THE PATIENT'S RIBS TO BREAK. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THE MANUFACTURER FOUND NO EVIDENCE OF CONTAMINATION AND NO DAMAGE. THE DEVICE WAS TURNED ON AND HAS NO FUNCTIONAL FAILURE OR ERROR CODES. LABEL WAS CORRECT AND THE HMR 02:00.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED THE PATIENT'S RIBS TO BREAK. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698977 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES, INC. R500055-000

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Other