BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASIS

    MDR report key: 7151931 · Received December 28, 2017

    Report

    Report Number
    8030405-2017-00004
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    HITACHI LTD, HEALTHCARE BUSINESS UNIT
    Product Code
    LNH
    PMA / PMN Number
    K093044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE OASIS IS A 1.2 TESLA VERTICAL FIELD (OPEN) MRI SYSTEM. THE PATIENT TABLE HAS A MOVABLE TOP THAT IS MOTORIZED AND IS USED TO POSITION THE PATIENT WITHIN THE MAGNET. BELOW THE TABLETOP, THERE IS A ALUMINUM BAND IN A RECESSED TRACK THAT COVERS A CHAIN DRIVE. THE BAND IS ONLY VISIBLE WHEN THE TABLETOP IS EXTENDED INTO SCANNING POSITION. THE PATIENT WOULD NEVER BE IN CONTACT WITH THIS SURFACE AS THE BAND IS FULLY COVERED WHEN THE TABLETOP IS RETRACTED TO THE POSITION WHERE THE PATIENT IS LOADED/UNLOADED. WHEN EXTENDED, THE TECHNOLOGIST BRUSHED HIS FINGER ACROSS THE BAND AN CAUGHT IT SUFFICIENTLY TO RAISE IT OUT OF THE RECESSED AREA AND ALLOW THE EDGE TO CUT HIS FINGER. THIS IS THE SECOND REPORT OF THIS KIND FOR THE OASIS PRODUCT. SEE 8030405-2017-00002. THERE HAVE BEEN NO CHANGES TO THE MECHANISM SINCE THE PRODUCT INCEPTION IN 2009. HITACHI IS STUDYING IF A DESIGN CHANGE IN WARRANTED.

    Description of Event or Problem · 1

    THE TECHNOLOGIST WAS SETTING UP A PATIENT EXAM ON THE HITACHI OASIS MRI SYSTEM ON (B)(6) 2017. THE TECHNOLOGIST WAS WALKING BY THE TABLE TO TAKE A PATIENT OFF AND RAN HIS FINGER ACROSS THE METAL TAPE THAT RUNS DOWN THE CENTER OF THE TABLE. THE TABLE WASN'T IN MOTION. THE TECHNOLOGIST WENT TO URGENT CARE BECAUSE HE COULD NOT STOP THE BLEEDING. HITACHI FOLLOW-UP ON 12/12/2017, THE TECHNICIAN RECEIVED NO STITCHES, NO OTHER FOLLOW-UP WITH A DOCTOR, AND IS 95% HEALED. HE WAS TOLD TO JUST KEEP IT CLEAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931855 OASIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH HITACHI LTD, HEALTHCARE BUSINESS UNIT OASIS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention