BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 2233616 · Received September 2, 2011

    Report

    Report Number
    2020563-2011-00018
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    June 4, 2011
    Report Date
    September 2, 2011
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE MRI SYSTEM WAS RAMPED DOWN AND THE DRIP STAND WAS REMOVED. VERY LITTLE DAMAGE WAS NOTED. AN EVALUATION OF THE SYSTEM WAS CONDUCTED AFTER IT WAS RAMPED UP AND THE SYSTEM IS 100% OPERATIONAL. NO IMAGE QUALITY ISSUES. THE NURSE CUT THE FOREHEAD WITH 1 OR 3CM, AND WAS TREATED WITH AROUND SEVERAL STITCHES. METHOD: THE DEVICE WILL BE EVALUATED TO ASCERTAIN ANY DAMAGE CAUSED BY DRIP STAND. ADDITIONAL EVALUATION IS NOT REQUIRED. THIS REPORT IS BEING FILED AS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS DURING AN INTERNAL AUDIT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE MRI SYSTEM WAS RAMPED DOWN AND THE DRIP STAND WAS REMOVED. VERY LITTLE DAMAGE WAS NOTED. AN EVALUATION OF THE SYSTEM WAS CONDUCTED AFTER IT WAS RAMPED UP AND THE SYSTEM IS 100% OPERATIONAL. NO IMAGE QUALITY ISSUES. THE PATIENT CUT THE FOREHEAD WITH 1 OR 3CM, AND WAS TREATED WITH AROUND SEVERAL STITCHES. METHOD: THE DEVICE WILL BE EVALUATED TO ASCERTAIN ANY DAMAGE CAUSED BY DRIP STAND. ADDITIONAL EVALUATION IS NOT REQUIRED. THIS REPORT IS BEING FILED AS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS DURING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    PATIENT WAS PREPPED BY FACILITY PERSONNEL AND WAS MOVED TO A MRI SAFE GURNEY. HOWEVER, HOSPITAL PERSONNEL DID NOT EXCHANGE THE DRIP STAND TO A NON-METALLIC DEVICE. WHEN THE PATIENT WAS MOVED INTO THE ROOM THE DRIP STAND WAS ATTRACTED TO THE MAGNET. THE DRIP STAND CONTACTED THE PATIENT AND CAUSED A LACERATION TO THE FOREHEAD. THE PATIENT RECEIVED STITCHES TO CLOSE THE LACERATION.

    Description of Event or Problem · 1

    PATIENT WAS PREPPED BY NURSE AND WAS MOVED TO A MRI SAFE GURNEY. HOWEVER, NURSE DID NOT EXCHANGE THE DRIP STAND TO A NON-METALLIC DEVICE. WHEN THE PATIENT AND NURSE WERE MOVED INTO THE ROOOM THE DRIP STAND WAS ATTRACTED TO THE MAGNET. THE DRIP STAND CONTACTED THE NURSE AND CAUSED A LACERATION TO THE FOREHEAD. THE NURSE RECEIVED STITCHES TO CLOSE THE LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA MAGNETIC RESONANCE SYSTEM LNH TOSHIBA AMERICA MEDICAL SYSTEMS MRT-2003

    Patients

    Seq Age Sex Outcome Treatment
    1