BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCOURAGE DEVICE

    MDR report key: 16022535 · Received December 21, 2022

    Report

    Report Number
    3004961434-2022-00009
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 6, 2022
    Report Date
    May 15, 2023
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BYI
    PMA / PMN Number
    K051383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN INCOURAGE DEVICE WAS ALLEGEDLY FILLING THE VEST WITH AIR AND WOULD NOT PULSATE. THE PATIENT HAD TO STOP THERAPY. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THE THIRD PARTY SERVICE CENTER FOUND THE DEVICE TO BE HEAVILY CONTAMINATED. THE DEVICE WAS SCRAPPED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE INCOURAGE DEVICE WAS FILLING THE VEST WITH AIR AND WOULD NOT PULSATE. THE PATIENT HAD TO STOP THERAPY. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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
    464863 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES, INC. R500055-011

    Patients

    Seq Age Sex Outcome Treatment
    1 Female