BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARE PLUS INCUBATOR

    MDR report key: 2977933 · Received February 21, 2013

    Report

    Report Number
    1121732-2013-00001
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 25, 2013
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K974349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE CONDUCTED AN ON-SITE EVALUATION OF THE UNIT WITH HOSPITAL PERSONNEL. THE UNIT WAS NOT USED ON ANY OTHER PTS AND WAS NOT CLEANED FOLLOWING THE ALLEGED EVENT. THE HOSPITAL STATED THAT THEIR CONCLUSION WAS THAT THE MAIN DOOR OF THE INCUBATOR WAS NOT LATCHED BY THE PARENTS AND THAT THE INFANT KICKED (OR IN SOME WAS PUSHED) THE MAIN DOOR OPEN, RESULTING IN THE INFANT FALLING TO THE FLOOR. A GE FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND FOUND THE FOLLOWING (NONE OF WHICH AFFECTED THE FUNCTION OF THE DEVICE): A) INNER WALLS MISSING ON THE SIDE PANELS AND MAIN DOOR; B) POWER CORD HOLDER TO FILTER COVER WAS BENT; AND C) STRESS FRACTURES ON THE BASE LOWER TRAY. THE HOSPITAL RISK MANAGER STATED THAT, WHEN THE REPORTED EVENT OCCURRED, THE MOTHER HAD FINISHED BREAST FEEDING, AND THE NURSE RETURNED THE INFANT TO THE INCUBATOR. THE NURSE THEN STARTED TO ATTEND TO OTHER PTS IN THE NICU. THE PARENTS SUBSEQUENTLY LEFT THE NICU. HOWEVER, BEFORE LEAVING THE ROOM, IT IS FELT THAT THE PARENTS HAD SOME INTERACTION WITH THE BABY AFTER THE NURSE PLACED THE INFANT IN THE INCUBATOR. THERE WERE NO DIRECT WITNESSES TO THE REPORTED EVENT. THE PREUSE CHECKOUT WAS PERFORMED PRIOR TO THIS PT BEING PLACED IN THE INCUBATOR. THE INCUBATOR DOORS, PORTHOLES AND ALL LATCHES WERE FOUND TO BE SECURELY ATTACHED AND IN GOOD WORKING CONDITION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AN INFANT FELL OUT OF THE INCUBATOR, LANDED ON THE FLOOR, AND INCURRED A "NONDISPLACED SKULL FRACTURE". THE HOSPITAL STATED THAT "CARE WAS NOT EXTENDED DUE TO THE FALL." THE PT HAS SINCE BEEN RELEASED FROM THE HOSPITAL. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76193 CARE PLUS INCUBATOR NEONATAL INFANT INCUBATOR FMZ OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other