BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0T SIGNA HDXT MR SYSTEM

    MDR report key: 2073578 · Received April 27, 2011

    Report

    Report Number
    2183553-2011-00018
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNOLOGIST WAS POSITIONING A PT ON THE TABLE AND WHEN THE LOW PROFILE CARRIAGE ASSEMBLY (LPCA) CAME OUT TO ATTACH TO THE CRADLE, IT OVERSHOT THE AREA WHERE IT SHOULD HAVE LATCHED ONTO THE CRADLE. IN TRYING TO MOVE THE LPCA TO CORRECTLY LATCH, THE TECHNOLOGIST WAS USING BOTH HANDS AND THE LPCA DROPPED DOWN OFF THE CRADLE AND PINNED HER INDEX FINGER OF HER LEFT HAND AND HER INDEX AND MIDDLE FINGERS OF HER RIGHT HAND. SHE USED HER RIGHT HAND AND WAS PULLING THE LPCA UP TO FREE HER LEFT INDEX FINGER. A GE HEALTHCARE FIELD ENGINEER ON SITE WAS ALERTED AND CAME TO HELP GET THE TECHNOLOGIST'S FINGERS FREE. SHE WAS EXAMINED BY A PHYSICIAN AND X-RAYS WERE PERFORMED. SHE SUSTAINED A NON-DISPLACED FRACTURE OF THE DISTAL PHALANX OF THE 2ND (INDEX) FINGER. SHE WAS PLACED IN A SPLINT AND WAS ALLOWED TO RETURN TO NORMAL DUTIES. THE PT THAT WAS ON THE TABLE DURING THE INCIDENT DID NOT SUSTAIN ANY INJURIES. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0T SIGNA HDXT MR SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention