BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 1604473 · Received February 8, 2010

    Report

    Report Number
    8030405-2010-00004
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 5, 2010
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K052172
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B) (6) 2010, HITACHI WAS MADE AWARE OF THE EVENT, BUT WAS NOT AWARE OF THE PT INJURY. THAT SAME DAY, HITACHI SERVICE CONFIRMED THAT THE APPROPRIATE MAGNETIC FIELD WARNING SIGNS WERE CLEARLY POSTED ON THE SCAN ROOM DOOR. AS THE MAGNET IS ALWAYS ON, THE DEVICE ITSELF DID NOT MALFUNCTION. HITACHI ALSO SUPPLIES MRI SAFETY TRAINING MATERIALS WITH EACH SYSTEM. OPERATOR'S MANUALS CONTAIN MAGNET SAFETY WARNINGS. HITACHI CONFIRMED THAT THE STAFF HAD RECEIVED MAGNET SAFETY TRAINING. WHEN THE SITE REPORTED THE PT INJURY ON 2/5/10, THEY INDICATED THAT THE PT HAD TO WAIT OVER AN HOUR FOR THE NURSING HOME TRANSPORTATION AND NEITHER AT THE TIME OF THE EVENT OR WHILE WAITING DID THE PT REPORT ANY DISCOMFORT. THE SITE REPORTED THAT THE PT WAS NOT SEDATED AT THE TIME OF THE EXAM.

    Description of Event or Problem · 1

    ON (B) (6) 2010, WHILE PREPARING TO SCAN A PT ON THE HITACHI ECHELON MRI SYSTEM, THE PT'S WHEELCHAIR WAS ATTRACTED TO THE MAGNET. ONE OF THE TWO TECHNOLOGISTS IN THE ROOM AT THE TIME WAS PINNED BETWEEN THE CHAIR AND THE MAGNET. THE OTHER TECHNOLOGIST DECIDED TO PRESS THE EMERGENCY RUNDOWN UNIT (ERDU) BUTTON WHICH QUENCHED THE MAGNET TO DROP THE MAGNETIC FIELD (QUENCHING IS THE ONLY WAY TO REMOVE THE FIELD IN AN EMERGENCY). THE PINNED TECHNOLOGIST WAS FREED AND WAS NOT INJURED. ON (B) (4) 2010, HITACHI CONTACTED THE SITE ON A ROUTINE FOLLOW UP TO CHECK ON THE TECHNOLOGIST AND CONFIRM THAT THERE WAS NO INJURY. THE SITE REPORTED THEN THAT THE PT HAD BEEN SITTING ON THE MRI TABLE WHEN THE INCIDENT OCCURRED AND DURING THE CONFUSION, STARTED TO FALL TO THE FLOOR. THE TECHNOLOGIST THAT QUENCHED THE MAGNET SAW HER AND HELPED HER DOWN TO THE FLOOR INSTEAD OF TRYING TO LIFT HER BACK ON THE TABLE ALONE. A FEW MINUTES LATER, THE PT WAS LIFTED AND LAID ON THE TABLE WHILE THE ROOM WAS PUT BACK IN ORDER. THEN THE PT WAS MOVED TO THE WAITING ROOM TO WAIT FOR TRANSPORTATION TO HER NURSING HOME. AT THE TIME, SHE DID NOT INDICATE SHE WAS INJURED. THE NEXT DAY THE HOME CALLED TO INDICATE THE PT HAD A FRACTURED LEG. THE SITE DID NOT INFORM HITACHI AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH HITACHI MEDICAL CORP. ECHELON

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention