BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA MR450W

    MDR report key: 2459609 · Received February 14, 2012

    Report

    Report Number
    2183553-2012-00009
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K091536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GE HEALTHCARE FIELD ENGINEER SUSTAINED A NON-DISPLACED FRACTURE OF THE DISTAL PHALANX OF THE SECOND FINGER ON HIS RIGHT HAND WHILE SERVICING AN OPTIMA (B)(4) . THE FIELD ENGINEER WAS CHANGING A DOCKING MOTOR AT BASE OF THE 450W MAGNET, HE LIFTED THE TOP COVER OFF THE DOCK ASSEMBLY AND WAS REMOVING THE MOTOR WHEN THE MAGNETIC FIELD PULLED THE MOTOR FROM HIS HAND AND ONTO SIDE OF MAGNET. THE FIELD ENGINEER WENT TO THE EMERGENCY DEPT WHERE THEY TOOK X-RAYS AND PLACED HIM IN A REMOVABLE SPLINT AND PRESCRIBED PAIN MEDICATION. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA MR450W MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other