BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YM101 PULSE OXIMETER

    MDR report key: 12518517 · Received September 22, 2021

    Report

    Report Number
    MW5104153
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    September 21, 2021
    Report Date
    September 21, 2021
    Manufacturer
    SHENZHEN YIMI LIFE TECHNOLOGY CO.,LTD
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BRADYCARDIA EPISODE AND NOTICED THAT, WHEN MY HEART RATE WAS AT 50BPM OR LESS, THE DEVICE WAS OFTEN REPORTING MY HEART RATE AS BEING THE DOUBLE OF ITS EFFECTIVE VALUE. LUCKILY, I HAD OTHER DEVICES (PORTABLE EKG, CUFF, AND APPLE WATCH) THAT ALL REPORTED MY LOW HR PROPERLY AND HELPED ME TAKE THE RIGHT NEXT STEPS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408742 YM101 PULSE OXIMETER OXIMETER DQA SHENZHEN YIMI LIFE TECHNOLOGY CO.,LTD YM101

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR