BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESVENT CPAP IBREEZE 20 A

    MDR report key: 16016367 · Received December 19, 2022

    Report

    Report Number
    MW5113867
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    December 15, 2022
    Report Date
    December 15, 2022
    Manufacturer
    RESVENT MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    QOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE A RESVENT IBREEZE CPAP 20A MACHINE. THE WATER CHAMBER IS BUILDING UP BLACK MOLD AND BIO FILM IN A RELATIVELY SHORT PERIOD OF TIME. THE DESIGN OF THE WATER CHAMBER MAKES IT DIFFICULT TO IMPOSSIBLE TO CLEAN EFFECTIVELY. THE HEATING PLATE GROWS BIO FILM ON THE PLATE AND UNDER THE PLATE GASKET. THE PLASTIC CHAMBER HAS MANY CORNERS AND AREAS THAT ARE DIFFICULT TO IMPOSSIBLE TO CLEAN. THERE IS A VOID IN THE TOP OF THE CHAMBER THAT CANNOT BE CLEANED AND GROWS BIO FILM AND MOLD. THIS IS A VERY POOR DESIGN AND COULD RESULT IN SEVERE ILLNESS TO USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630659 RESVENT CPAP IBREEZE 20 A CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT QOR RESVENT MEDICAL TECHNOLOGY CO., LTD. IBREEZE 20A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| O| S ASPRI, VITAMIN C, B12, B1 MULTI VITAMIN.| METOPROLOL, ATORVASTATIN.