BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA HDX

    MDR report key: 3841128 · Received May 13, 2014

    Report

    Report Number
    2183553-2014-00013
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K121676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MR TECHNOLOGIST WAS POSITIONING A PATIENT FOR A HEAD SCAN. THE PATIENT WAS REPORTEDLY MOVING ON THE BED, WHICH RESULTED IN THE HEAD COIL SLIDING VERTICALLY UNDER THE PATIENT TOWARD THE MAGNET. WHILE BRINGING UP THE TABLE, THE MR TECHNOLOGIST NOTICED THE BRIDGE WAS STARTING TO RAISE. WHEN THE BRIDGE WAS LIFTED, IT CREATED A GAP ON THE SIDE BETWEEN THE MAGNET COVER AND THE TABLE. THE TECHNOLOGIST LOWERED THE TABLE WITH HER RIGHT HAND ON THE PATIENT AND HER LEFT HAND ON THE SIDE OF THE MAGNET. THE BRIDGE REPORTEDLY CAME DOWN QUICKLY AND LANDED ON THE TECHNOLOGISTS'S LEFT RING FINGER. THE TRANSPORTER WHO HAD BROUGHT THE PATIENT TO THE MR ROOM CAME TO CHECK IF EXAM WAS DONE AND ASSISTED THE TECHNOLOGIST IN REMOVING HER HAND. THE TABLE WAS THEN UNDOCKED AND THE PATIENT WAS BROUGHT OUT OF THE ROOM. THE TECHNOLOGIST NOTED THAT HER RING FINGER WAS BENT AND WAS SENT TO THE EMERGENCY ROOM WHERE IT WAS DETERMINED THAT HER FINGER WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285383 1.5T SIGNA HDX MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other