BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLETTE 8000 INFANT INCUBATOR

    MDR report key: 12420841 · Received September 3, 2021

    Report

    Report Number
    12420841
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 21, 2021
    Report Date
    September 1, 2021
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BABY FELL OUT OF A DRAEGER MEDICAL INC ISOLETTE 8000 WHICH RESULTED IN A HEAD DEPRESSION FRACTURE AND SUBDURAL HEMATOMA. DEVICE WAS INSPECTED BY OUR BIOMEDICAL DEPARTMENT WHO NOTED THAT THE LATCHING MECHANISMS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321277 ISOLETTE 8000 INFANT INCUBATOR INCUBATOR, NEONATAL FMZ DRAEGER MEDICAL SYSTEMS, INC. MU20600

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA