BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY MR750W 3.0T

    MDR report key: 2508914 · Received March 27, 2012

    Report

    Report Number
    2183553-2012-00015
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K103327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE DISCOVERY MR750W 3.0T MR SYSTEM WORKED AS INTENDED WHEN IT ATTRACTED THE FERROUS OBJECT. THE CAUSE OF THE INCIDENT WAS USER ERROR AS THE (B)(6) DID NOT FOLLOW THE MAGNETIC FORCE WARNINGS POSTED AND DECIDED ON HIS OWN TO BRING THE SACK BARROW TROLLEY INTO THE MAGNET ROOM. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3RD PARTY PERSON (AN (B)(6)) BROKE HIS ARM AFTER A SACK BARROW TROLLEY WAS ATTRACTED BY THE MAGNET OF A DISCOVERY MR750W 3.0T MR SYSTEM. A GE HEALTHCARE FIELD SERVICE ENGINEER (GEHC FE) AND A CONTRACTOR WERE WORKING ON THE SYSTEM AND AS THEY WERE TRYING TO MOVE THE COIL CABINET TO GET MORE SPACE THE (B)(6) OFFERED TO HELP AND ENTERED THE ROOM. THE GEHC FE STOPPED HIM AND VERBALLY INFORMED HIM ABOUT THE MAGNETIC RISK/FORCE. AFTER THE THREE MEN WERE UNSUCCESSFUL MOVING THE CABINET, THE GEHC FE AND THE CONTRACTOR LEFT THE ROOM, AT THAT TIME THE (B)(6) WENT TO THE CONTROL ROOM, TOOK THE GEHC FIELD ENGINEER'S TROLLEY AND WENT BACK INTO THE ROOM TO TRY TO REMOVE THE CABINET. HE WAS TRAPPED BY THE TROLLEY AND BROKE HIS ARM. THIS WAS HIS OWN INITIATIVE AND WAS NOT REQUESTED BY GE HEALTHCARE. ALL WARNING MESSAGES WERE PRESENT ON THE DOOR OF THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY MR750W 3.0T MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other