BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOTRACE CORE

    MDR report key: 19423555 · Received May 30, 2024

    Report

    Report Number
    19423555
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 22, 2024
    Report Date
    April 30, 2024
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERMO TRACE CENTRAL DRAGER TEMP PROBE REF MX11000, LOT 230409. ON <DATE REDACTED>, WE HAD TWO SICK INFANT 6 HOURS APART NEED ADDITIONAL CARE IN OUR STABILIZATION BED IN THE NEWBORN NURSERY AND THE TEMP PROBE ON THE DRAGER WARMER WAS NOT PROPERLY READING THE INFANT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066414 THERMOTRACE CORE WARMER, INFANT RADIANT FMT DRAEGER MEDICAL SYSTEMS, INC MX11000 230409

    Patients

    Seq Age Sex Outcome Treatment
    1 123 YR Unknown