BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 15973333 · Received December 13, 2022

    Report

    Report Number
    3004961434-2022-00008
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 28, 2022
    Report Date
    February 8, 2022
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BYI
    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 RECEIVED INFORMATION ALLEGING A PATIENT WAS UNABLE TO USE THE INCOURAGE DEVICE AS SHE HAS 3 COMPRESSION FRACTURES IN HER BACK. THE PATIENT IS UNSURE IF THE DEVICE CAUSED THIS OR NOT. THERE WAS NO REPORT OF MEDICAL TREATMENT BEING REQUIRED. THE DEVICE WAS EVALUTAED BY A THIRD PARTY SERVICE CENTER. THE THIRD PARTY SERVICE CENTER FOUND EVIDENCE OF DUST AND LINT CONTAMINATION TO THE AIR INLET AND INTAKE COVER. THE DEVICE WAS TESTED AND THE DEVICE PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WAS UNABLE TO USE THE INCOURAGE DEVICE AS SHE HAS 3 COMPRESSION FRACTURES IN HER BACK. THE PATIENT IS UNSURE IF THE DEVICE CAUSED THIS OR NOT. THERE WAS NO REPORT OF MEDICAL TREATMENT BEING REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734879 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES, INC. R500055-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other