BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T MAGNETOM ESPREE MRI

    MDR report key: 4152635 · Received October 2, 2014

    Report

    Report Number
    MW5038514
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SIEMENS MEDICAL
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAVING AN MR PELVIS (UTERINE) EXAM EXHIBITED SIGNIFICANT LOCALIZED HEATING DISCOMFORT IN A CRESCENT SHAPED BAND ACROSS HER PELVIC. PT DESCRIBED A SINGLE EPISODE OF SHOOTING PAIN IN RIGHT ADNEXA AS WELL AS INTENSE BACK HEATING. ERYTHEMIC AREA NOTED BY RADIOLOGIST WHO EXAMINED PT IMMEDIATELY UPON CESSATION OF SCAN. THE 1.5T ESPREE UNIT WITH RECEIVE ONLY 6-CHANNEL BODY MATRIX COIL AND SPINE MATRIX COIL UTILIZED FOR EXAM. PARALLEL IMAGING GRAPPA FACTOR OF 2 IN TRIPLE MODE ALSO USED. MACHINE OPERATED ENTIRELY IN "NORMAL MODE"; "FIRST LEVEL" OPERATION WAS NEITHER REQUESTED NOR INITIATED BY THE MR TECHNOLOGIST. ENVIRONMENTAL TEMPERATURE MAINTAINED AT 19DEGC FOR ENTIRE DURATION OF SCAN WITH SCANNER BORE FAN ON MAXIMUM. PT POSITIONED WITH NO SKIN TO SKIN CONTACT AND NO CROSSING OF EXTREMITIES. PROPER PADDING AND A MINIMUM OF 5MM AIR/PADDING GAP MAINTAINED FOR ENTIRE EXAM. PT WAS CHANGED INTO HOSPITAL SCRUBS FOR EXAM. NO LOOPING OF COIL CABLING EVIDENT, COIL PLUGGED INTO TABLE PORT SECURELY, AND COIL CUSHION ALSO USED. ESTABLISHED SEQUENCE AND PROTOCOL SELECTION USED. NO METALLIC OR FOREIGN OBJECTS WERE IN OR AROUND THE PT DURING SCANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613942 1.5T MAGNETOM ESPREE MRI 1.5T MAGNETOM ESPREE MRI LNH SIEMENS MEDICAL 1.5T MAGNETOM ESPREE

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other ANTECUBITAL VEIN NEAR END OF EXAMINATION| 12ML MAGNEVIST (GADOPENTETATE DIMEGLUMINE) FROM A| 20ML PREFILLED SYRINGE INJECTED INTO LEFT,