BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINGERTIP PULSE OXIMETER

    MDR report key: 10074948 · Received May 19, 2020

    Report

    Report Number
    MW5094583
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 16, 2020
    Manufacturer
    SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD.
    Product Code
    DQA
    UDI-DI
    06972911370012
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WE PURCHASED A (SHENZHEN YIMI LIFE TECHNOLOGIES) FINGER TIP PULSE OXIMETER THROUGH (B)(6). I AM WRITING WITH SEVERAL CONCERNS: THE MARKETING MATERIAL ON (B)(6) INDICATED THE PRODUCT WOULD WORK FOR ADULTS AND CHILDREN, THE MARKETING MATERIALS INCLUDED WITH THE PRODUCT INDICATE FOR ADULT USE ONLY; THE PRODUCT IS LABELED RX ONLY BUT (B)(6) NEVER ASKED FOR A COPY OF A PRESCRIPTION; IS (B)(6) VAWD CERTIFIED ENABLING THEM TO SELL PRESCRIPTION DEVICES?; SHENZHEN YIMI LIFE DOES NOT APPEAR TO HAVE A PRESENCE IN THE U.S.A; THE PACKAGE INSERT LISTS VALIDATION TEST RESULTS BASED ON A SAMPLE OF ELEVEN PATIENTS; IS THIS SAMPLE STATISTICALLY SIGNIFICANT? FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536854 FINGERTIP PULSE OXIMETER OXIMETER DQA SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD. YM101 06972911370012

    Patients

    Seq Age Sex Outcome Treatment
    1