BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4202102 · Received October 23, 2014

    Report

    Report Number
    4202102
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 23, 2014
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    A PORTABLE HEAD CT SCAN WAS NEEDED ON A PEDIATRIC PATIENT WITH A TRACHEOSTOMY ON VENTILATION. THE PATIENT REQUIRED TO LAY ON HEAD-REST THAT EXTENDS FAR BEYOND THE TOP OF THE BED. THE SUPPORT WAS PLACED ON THE BED CORRECTLY BY THE CT TECHNICIAN BUT WHEN THE PATIENT WAS MOVED ONTO IT, IT ABRUPTLY DROPPED DOWN A COUPLE INCHES. THE PATIENT WAS VERY AFRAID TO GET BACK ONTO IT.THIS IS A CUSTOM DESIGNED BRACKET FOR AN ADULT SIZED BED.UPON REVIEW OF THE BRACKET IT APPEARED THAT THE BUSHINGS WERE WORN.THE MANUFACTURER IS EVALUATING AND POSSIBLY REDESIGNING THE DEVICE. THEY ASKED TO COME ON SITE TO REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677401 * BRACKET JAK NEUROLOGICA CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR