BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCUBATOR 8000 IC

    MDR report key: 2499730 · Received March 9, 2012

    Report

    Report Number
    9611500-2012-00013
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    January 24, 2012
    Report Date
    March 9, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    FMZ
    PMA / PMN Number
    K913394
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN STARTED, THE RESULTS WILL BE PART OF A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BABY WENT OUT THE INCUBATOR THROUGH THE LEFT FRONT WINDOW; THE BED WAS IN TRENDELENBURG POSITION AND THE BABY WAS IN POSITIONING AID HUG. LATER, THE CUSTOMER STATED THAT A HEAD INJURY FROM THE ACCIDENTAL FALL FROM THE INCUBATOR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCUBATOR 8000 IC NEONATAL INCUBATOR FMZ DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening