BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVII

    MDR report key: 10945632 · Received December 4, 2020

    Report

    Report Number
    10945632
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 2, 2020
    Manufacturer
    MONICA HEALTHCARE LIMITED
    Product Code
    OSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOVII MONITOR TRANSPOSED FETAL HEART RATE AND MATERNAL HEART RATE- VISUALIZED ON THE TRACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408772 NOVII UTERINE ELECTROMYOGRAPHIC MONITOR OSP MONICA HEALTHCARE LIMITED ID YOM6961-MON

    Patients

    Seq Age Sex Outcome Treatment
    1 8030 DA