BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALOCC

    MDR report key: 976521 · Received November 27, 2007

    Report

    Report Number
    976521
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    November 12, 2007
    Report Date
    November 27, 2007
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE TECH MOVED THE OVERHEAD CABLING, IT FELL FROM THE HOOK AND HIT HER ON THE NECK, RESULTING IN AN INJURY. THE EMPLOYEE WENT TO EMPLOYEE OCCUPATIONAL HEALTH. SHE SUSTAINED A NECK SPRAIN AND WAS PLACED ON RESTRICTED DUTY AND RECEIVED PAIN MEDICATION FOR PAIN CONTROL. GE REP DID COME AND CHECK THE EQUIPMENT. THE HOOK WAS TIGHTENED. WE CHECKED OTHER GE X-RAY EQUIPMENT - FOUND OTHER HOOKS THAT NEEDED TO BE TIGHTENED. THE GE REP TOLD US THAT THIS WAS THE WAY THE HOOKS WERE MADE AND THEY HAD RECEIVED NO COMPLAINTS. I LOOKED AT THE HOOKS - THEY DO NOT LOOK STURDY ENOUGH AND CERTAINLY WERE NOT TIGHT ENOUGH. THAT CABLING JUST SLIPPED OUT OF THE HOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALOCC X-RAY KPR GE MEDICAL SYSTEMS 2266999 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NO OTHER THERAPIES| NO OTHER THERAPIES