BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRBORNE 750I INFANT

    MDR report key: 4591765 · Received March 6, 2015

    Report

    Report Number
    4591765
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    December 7, 2014
    Report Date
    March 6, 2015
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    A NEWBORN WAS IN TRANSIT TO THE NICU IN THE DEVICE. AS THE NURSE ENTERED THE ROOM WITH THE DEVICE, THE TOP PORTION OF THE DEVICE STARTED TO SLIDE OFF THE BASE. THE NURSE IMMEDIATELY STOPPED AND REMOVED THE NEWBORN FROM THE DEVICE. THE NEWBORN WAS TRANSPORTED IN ARMS THE REST OF THE WAY INTO THE ROOM AND PLACED IN THE WARMER.THE DEVICE WAS REMOVED FROM SERVICE AND SENT TO BIOMED FOR EXAMINATION. BIOMED DETERMINED THAT THE 4 BOLTS THAT HOLD THE TOP PORTION OF THE DEVICE HAD COME LOOSE. THE LOOSE BOLTS WERE REPLACED. THE BOLTS ARE LOCATED NEAR SHOCK ABSORBERS, WHICH MAY HAVE CONTRIBUTED TO THE LOOSE BOLTS. OUR BIOMED TEAM DETERMINED THAT THE BOLTS SHOULD BE ADDED TO THE 6 MONTH PREVENTATIVE MAINTENANCE SCHEDULE FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156438 AIRBORNE 750I INFANT INCUBATOR, NEONATAL TRANSPORT FPL INTERNATIONAL BIOMEDICAL, LTD. 750I *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 *