BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS

    MDR report key: 1633047 · Received March 15, 2010

    Report

    Report Number
    8030405-2010-00006
    Event Type
    Other
    Date Received
    March 15, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 15, 2010
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K072279
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HITACHI SERVICE VISITED THE SITE ON (B)(4) 2010 AND AGAIN ON (B)(4) 2010. BECAUSE THE SITE REPORTED PROBLEMS WITH MULTIPLE PTS USING 2 DIFFERENT RF RECEIVE COILS, PERFORMANCE AND HEAT TESTS WERE DONE ON THOSE COILS AS WELL AS ON THE UPPER TRANSMITTER COVER. ALL OF THE COILS AND THE COVER HAD SURFACE TEMPERATURE READINGS UNDER 80 DEGREES USING THE SAME SCAN PROTOCOLS AS THE COMPLAINING PTS. THE SITE REPORTED THAT THE COILS WERE USED ON OTHER PTS BETWEEN (B)(6) WHEN PT THREE WAS SCANNED AND THEIR CALL TO HITACHI ON (B)(6). NO PROBLEMS WERE REPORTED ON THESE PTS. THE SITE REPORTED THAT ALL 3 PTS WERE LARGE. PT THREE'S ABDOMEN WAS TOUCHING THE TRANSMITTER COVER SURFACE, ALTHOUGH THERE WAS NO DIRECT SKIN CONTACT AS HER TOP AND A SHEET WERE BETWEEN THE COVER AND HER SKIN. IT IS POSSIBLE THAT THE LACK OF AIRFLOW COULD HAVE CAUSED SOME HEAT BUILDUP IN THE ABDOMINAL AREA DUE TO THE NORMAL ABSORPTION OF RF ENERGY FROM THE MRI SCAN. THE TECHNOLOGIST DID NOT NOTE ANY SKIN REDNESS ON ANY OF THE COMPLAINING PTS AT THE TIME THEIR EXAM WAS COMPLETED. ALL PTS REPORTED THEIR SENSATIONS AFTER THE EXAM WAS DONE. THE SITE REPORTED THAT THE IMAGE QUALITY OF PT THREE'S EXAM WAS NOT GOOD. HITACHI CLINICAL SCIENCE REVIEWED THE IMAGES AND NOTED SOME ARTIFACTS. THE ARTIFACTS WERE REVIEWED BY SERVICE AND DETERMINED TO BE RELATED TO RANDOM NOISE. SERVICE CONFIRMED WITH THE SITE THAT THE NOISE HAS NOT RE-OCCURRED. SUCH NOISE CAN BE CAUSED BY VARIOUS EXTERNAL ENVIRONMENTAL SOURCES AND ARE NOT UNCOMMON. BASED ON OUR EVALUATIONS, NO SYSTEM MALFUNCTION WAS DETECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, HITACHI RECEIVED A REPORT FROM A SITE CLAIMING 3 PTS HAD COMPLAINED OF VARIOUS BURNING SENSATIONS OVER THE LAST 2 WEEKS AFTER BEING SCANNED ON A HITACHI OASIS MRI SYSTEM. THE FIRST TWO PTS INDICATED THAT THE SENSATION SUBSIDED AFTER THE SCAN WAS COMPLETED. PT #3, SCANNED ON (B)(6) 2010, REPORTED THAT SHE FELT BURNING FROM "INSIDE OUT." AFTER THE SCANS, ALL THE PTS WERE EXAMINED AND SHOWED NO SIGNS OF SKIN BURNS. ON (B)(6) 2010, PT #3 RETURNED TO THE SITE CLAIMING THAT HER PAIN HAD NOT SUBSIDED AND THAT SHE HAD SOUGHT TREATMENT AT AN ER FOR THE PAIN. THE PT WAS SEEN BY THE RADIOLOGIST AND THE MRI IMAGING SUPERVISOR. THEY EXAMINED THE PT'S ABDOMEN AND NOTED ONLY A SPOT ABOUT THE SIZE OF THE HEAD OF A PIN, BUT COULD NOT DETERMINE IF IT WAS A BURN. THE PT HAS PRE-EXISTING ACID REFLUX AND THE SYMPTOMS SHE REPORTED ON (B)(6) WERE CONSISTENT WITH THAT CONDITION ACCORDING TO THE SUPERVISOR. THE SUPERVISOR STATED THAT SHE BELIEVED THAT THE EMERGENCY ROOM TREATED THE PT FOR ACID REFLUX BASED ON THE DESCRIPTION OF THE LIQUID, THE ER DOCTOR GAVE HER TO DRINK. THE ER ALSO GAVE THE PT PERCOCET, BUT THE PT HAD ALREADY BEEN TAKING IT FOR OTHER REASONS. THE SITE HAD TRIED TO FOLLOW UP, BUT HAS NOT BEEN ABLE TO CONTACT THE PT.

    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 58 YR Required Intervention