BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE SYSTEM

    MDR report key: 8019124 · Received October 30, 2018

    Report

    Report Number
    3004961434-2018-00002
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 2, 2018
    Manufacturer
    RESPIRATORY TECHNOLOGIES INC.
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BEEN USING VEST THERAPY SUCCESSFULLY FOR 6 MONTHS, THEN WAS HOSPITALIZED FOR AN UNRELATED CONDITION. AFTER BEING DISCHARGED, PATIENT RESUMED VEST THERAPY AND AFTER THREE SESSIONS, PATIENT DEVELOPED SHORTNESS OF BREATH. PATIENT WAS TAKEN TO THE ER AND FOUND TO HAVE A PNEUMOTHORAX ON THE LEFT AND WAS ADMITTED. SPOUSE STATES THAT HOSPITAL PHYSICIANS DO NOT KNOW CAUSE OF PNEUMOTHORAX. FOLLOWED UP WITH PATIENT'S PULMONOLOGIST WHO SAID THAT AT THIS TIME THEY FEEL THE PNEUMOTHORAX IS UNRELATED TO VEST USE, HOWEVER THEY CANNOT MAKE AN ABSOLUTE DETERMINATION. RESULTS OF MANUFACTURER TESTING OF RETURNED DEVICE: THE DEVICE WAS FOUND TO BE OPERATING NORMALLY WITHIN DEFINED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860551 INCOURAGE SYSTEM PULSATING VEST THERAPY BYI RESPIRATORY TECHNOLOGIES INC. ICS-1M-US-A 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R