BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONICA FETAL MONITORING SYSTEM

    MDR report key: 8138920 · Received December 5, 2018

    Report

    Report Number
    MW5081895
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 3, 2018
    Manufacturer
    MONICA HEALTHCARE LTD.
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NURSE REMOVED THE WIRELESS MONICA MONITORING SYSTEM FROM THE PATIENT'S ABDOMEN AS IT KEPT ALARMING -STATING TO ADJUST ELECTRODE. UPON REMOVAL OF THE ELECTRODES, THE NURSE FOUND THE SKIN WAS REDDENED AND INFLAMED. THERE WAS ONE ELECTRODE ON THE PATIENT'S LEFT SIDE THAT WAS AN ABRASION AND WAS BLOOD TINGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974988 MONICA FETAL MONITORING SYSTEM SYSTEM, MONITORING, PERINATAL HGM MONICA HEALTHCARE LTD. GTIN(01): 05060433670053 (10):500904

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other