BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT INCUBATOR 100

    MDR report key: 21900979 · Received April 24, 2025

    Report

    Report Number
    MW5169501
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 21, 2025
    Report Date
    April 21, 2025
    Manufacturer
    ATOM MEDICAL CORPORATION
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RED STAINING/DISCOLORATION ON THE BRACKET HOLDING THE T-PIECE RESUSCITATORS TO EACH ATOM INCUBATOR. CAN BE MISTAKEN FOR BLOOD/SOILED/NOT CLEANED. WAS INFORMED BY BIOMED THAT THIS IS A TYPE OF GLUE TO SECURE THE BOLT THAT WAS INSTALLED BY ATOM DURING BUILD. ATOM IV POLES NOTED TO BE LOOSE AT THE WHITE HINGE ON 3 ATOM INCUBATORS. NOTE THAT THESE POLES HOLD 10KG MAX. I WEIGHED OUR ALARIS PUMP AND EACH MODULE. ONE ALARIS IV PUMP/BRAIN CAN HOLD UP TO FOUR MODULES MAX, WHICH IS COMMONLY USED IN A CRITICAL NICU PATIENT. IT WEIGHED APPROXIMATELY 10KG, PLUS IF YOU ADD THE IV BAGS, TUBING AND FEEDING PUMP IT WILL BE OVER 10KG. IF THIS IS CONTRIBUTING TO THE MALFUNCTION, WE WILL HAVE TO START USING STANDALONE IV POLES FOR ANY BABY NEEDING MORE THAN 2 MODULES AND A FEEDING PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370491 INFANT INCUBATOR 100 INCUBATOR, NEONATAL FMZ ATOM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown