BEUDAMED
    FDA Adverse Event Summary report: N

    RESVENT IBREEZE CPAP

    MDR report key: 14488763 · Received May 23, 2022

    Report

    Report Number
    MW5109887
    Date Received
    May 23, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 23, 2022
    Manufacturer
    RESVENT MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    QOQ
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BASED ON MY PERSONAL EXPERIENCE AND CONVERSATION WITH THE U.S. DISTRIBUTOR (B)(4), I BELIEVE THAT THE WIFI ENABLED VERSION OF THIS MACHINE IS BEING IMPORTED AND SOLD IN THE UNITED STATES ILLEGALLY. THE WIFI ON THE MACHINE IS MALFUNCTIONING, AND UNABLE TO TRANSMIT DATA TO MY CPAP STORE. AS A RESULT, I CAN'T COMMUNICATE MY COMPLIANCE DATA FOR INSURANCE COVERAGE PURPOSES. IN ADDITION, THE SOFTWARE IN THE MACHINE ALSO HAS SEVERAL BUGS THAT WON'T ALLOW THE DATE AND TIME TO BE CHANGED IF ENTERED INCORRECTLY WHEN INITIALLY SETTING UP THE MACHINE. THUS, SUBSEQUENT CPAP USAGE DATES ARE RECORDED INCORRECTLY. HARD COPY PRINTOUTS OF THESE DATA ARE UNREADABLE. THE U.S. DISTRIBUTOR, (B)(4) MADE THE FOLLOWING STATEMENT ON 11/30/2021: "THE [RESVENT] CPAPS ARE NOT APPROVED FOR WI-FI AT THIS TIME". (B)(4). MY RESVENT IBREEZE 20A WAS SOLD TO ME BY, (B)(4) IN (B)(6). (B)(4); A (B)(6)SEARCH WILL SHOW THAT THERE ARE MANY COMPANIES SELLING THIS PRODUCT ONLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192715 RESVENT IBREEZE CPAP NON-CONTINUOUS VENTILATOR FOR EMERGENCY USE QOQ RESVENT MEDICAL TECHNOLOGY CO., LTD. 20A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown