BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1941748 · Received December 9, 2010

    Report

    Report Number
    1941748
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 9, 2010
    Manufacturer
    PEDIGO PRODUCTS, INC.
    Product Code
    NZG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE REPORTED THAT SHE WAS TRANSPORTING A PATIENT IN THE BASSINET (WITH A NORMAL SPEED) PUSHING IT SIDEWAYS IN THE HALLWAY, AND PASSED OVER AN EXPANSION JOINT. THE WHEELS GOT CAUGHT AND THE FRONT LEFT WHEEL DISLODGED FROM THE LEG JOINT. THE CLEAR BASSINET PORTION TIPPED OUT OF THE METAL FRAME AND THE PATIENT FELL OUT ON TO THE FLOOR.==================================================================REPORTER INDICATED "A HEAD CT WAS DONE AND FREQUENT NEURO CHECKS" WERE PERFORMED ON THE PATIENT" AND "THE PATIENT WAS TRANSPORTED BY THE NURSE." THERE WAS NO PREVENTIVE MAINTENANCE SCHEDULE FOR THIS DEVICE PRIOR TO THE EVENT. "A MAINTENANCE SCHEDULE HAS BEEN SINCE IMPLEMENTED." THE WHEELS WERE ALSO 11 YEARS OLD. "ON INSPECTION THE PLASTIC RIDGES APPEARED WORN WHICH MAY HAVE CONTRIBUTED TO THE CASTER AND WHEEL FROM BECOMING DISLODGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BASSINET NZG PEDIGO PRODUCTS, INC. P-1110-A-SS *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY