BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASIS

    MDR report key: 4901656 · Received July 9, 2015

    Report

    Report Number
    8030405-2015-00008
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K093044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RECEIVER COIL IN USE HAS A RIBBED STRUCTURE THAT SNAPS IN PLACE OVER THE PATIENT'S BODY. THE TOP OF THE COIL CLEARS THE TOP OF THE MAGNET BORE BY LESS THAN 2CM, SO IT CREATES A PINCH HAZARD. IN THIS CASE THE OPERATOR INSTRUCTED THE PATIENT TO KEEP THEIR ARMS AT THE SITE OF THE COIL AWAY FROM THE BORE BUT THE PATIENT DIDN'T COMPLY. THE OPERATOR IS NEXT TO THE PATIENT TABLE IN CLEAR VIEW OF THE PATIENT WHEN OPERATING THE PATIENT TABLE TO MOVE THE PATIENT INTO THE MAGNET BORE. IT IS UNCLEAR WHETHER THE OPERATOR COULD HAVE REACTED FASTER TO RELEASE THE TABLE MOVE CONTROL BUTTON AND PREVENT THE INJURY. CURRENT OPERATOR INSTRUCTIONS STATE THAT THE OPERATOR IS RESPONSIBLE TO MONITORING THE PATIENT DURING TABLE MOTION TO PREVENT SUCH INJURIES. THE INSTRUCTIONS ARE ADEQUATE AND THE OPERATOR DID INSTRUCT THE PATIENT PROPERLY IN THIS CASE. HITACHI CLINICAL APPLICATIONS WAS ON SITE AT THE TIME TO DO INITIAL TRAINING BUT DID NOT WITNESS THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 AT 10:00AM WHILE BEING SET UP FOR AN MRI EXAM ON THE HITACHI OASIS MRI SYSTEM, A PATIENT PINCHED HIS HAND BETWEEN RECEIVER COIL AND MAGNET UPPER COVER. THE TECHNOLOGISTS GAVE INSTRUCTION TO KEEP HANDS AT SIDE BUT DURING THE TABLE MOVEMENT HE "HUGGED" THE COIL PUT HIS HAND IN POSITION TO GET PINCHED. THE INJURY WAS DESCRIBED AS AN ABRASION (SKIN PEEL) WITH MINIMAL BLEEDING. THE TECHNOLOGIST TREATED INJURY AND FINISHED EXAM. THE PATIENT REFUSED FURTHER TREATMENT AND FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446781 OASIS MAGNETIC RESONANCE IMAGING DEVICE LNH HITACHI MEDICAL CORPORATION OASIS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention