BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS

    MDR report key: 1543067 · Received November 20, 2009

    Report

    Report Number
    8030405-2009-00005
    Event Type
    Other
    Date Received
    November 20, 2009
    Date of Event
    October 27, 2009
    Report Date
    November 20, 2009
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TEMPERATURE TESTS WERE PERFORMED TO DETERMINE IF THERE WAS ANY HIGH TEMPERATURES DETECTABLE ON THE UPPER GANTRY OPENING COVER. TESTS WERE NEGATIVE. NO DEVICE MALFUNCTION WAS DETECTED. THE PT'S IMAGES WERE REVIEWED BY HITACHI AND WERE FOUND TO HAVE ACCEPTABLE IMAGE QUALITY AND WERE FREE OF IMAGE ARTIFACTS. BASED ON THE INFO GIVEN TO THE SITE ABUT THE INJURIES, THE AFFECTED AREAS WERE NOT IN DIRECT SKIN CONTACT WITH THE MRI RECEIVE COIL, CABLES, OR OTHER COMPONENTS OF THE OASIS SYSTEM.

    Description of Event or Problem · 1

    ON (B)(6)2009, THE PT WAS SCANNED ON A HITACHI OASIS OPEN MRI SYSTEM. THE PT RECEIVED A CERVICAL SPINE EXAM. THE PT WAS WEARING A GREEN POLO STYLE SHIRT. BECAUSE OF HER SIZE, HER ABDOMEN WAS TOUCHING THE UPPER SURFACE OF THE MRI GANTRY OPENING. BECAUSE THE ABDOMEN WAS CONTACTING THE GANTRY COVER, THE TECHNOLOGIST PLACED A EMPTY FILM ENVELOPE BETWEEN THE PT'S ABDOMEN AND THE COVER. THERE WAS NO DIRECT SKIN CONTACT TO ANY SURFACE. AFTER THE EXAM WAS COMPLETED, THE PT COMPLAINED OF A BURNING SENSATION ON HER ABDOMEN. THE TECHNOLOGIST EXAMINED THE PT'S ABDOMEN AND INDICATED THAT THERE WERE NO MARKS AND THE SKIN WAS PASTY WHITE. ADD'L SCANS THAT WERE SCHEDULED TO BE DONE WERE CANCELLED ON THE ADVICE OF THE TECHNOLOGIST AND RADIOLOGIST. THE PT WANTED TO CONTINUE THE EXAM. THE RADIOLOGIST EXAMINED THE PT'S ABDOMEN AND DID NOT NOTICE ANY MARKS OR OTHER INDICATION OF INJURY. SOMETIME AFTER THE PT RETURNED HOME SHE REPORTED TO THE SITE THAT A BLISTER DEVELOPED ON HER ABDOMEN AND SHE HAD "POPPED" IT. ON 11/11/09, HITACHI WAS INFORMED BY THE SITE THAT THE PT WAS UNDER A DOCTOR'S CARE, BUT WE HAVE NO INFO WHETHER THIS IS BECAUSE THERE WERE COMPLICATIONS FROM THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other