BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS

    MDR report key: 2273627 · Received September 26, 2011

    Report

    Report Number
    8030405-2011-00008
    Event Type
    Other
    Date Received
    September 26, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 30, 2011
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K072279
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HITACHI SERVICE TESTED THE SYSTEM ON (B)(6) 2011, FOR GENERAL PERFORMANCE AND HEATING IN THE AREA WHERE THE PT'S ABDOMEN CONTACTED THE RF TRANSMITTER COVER. USING THE SAME SCANNING PARAMETERS FROM THE PT'S EXAM, NO AREA ON THE TRANSMITTER COVER MEASURED HIGHER THAN 73 DEGREES F. THE RECEIVED COIL AND TRANSMITTER WERE CHECKED AND WERE OPERATING WITHIN SPECIFICATIONS. PT IMAGES WERE REVIEWED AND DID NOT SHOW ANY INDICATION THAT THE SYSTEM WAS MALFUNCTIONING. THE SAR LEVELS WERE REPORTED BY THE TECHNOLOGIST TO BE LESS THAN 2 W/KG FOR ALL THE SEQUENCES OF THE EXAM. THE EVIDENCE SUGGESTS THAT THE OASIS MRI SYSTEM DID NOT DIRECTLY CAUSE THE PT'S INJURY DUE TO MALFUNCTION OR MISUSE. WHILE HITACHI CANNOT DETERMINE THE DIRECT CAUSE OF THE INJURY, WE CANNOT RULE OUT THAT THE CLOSE PROXIMITY OF THE PT'S SKIN TO THE RF TRANSMITTER MAY HAVE CAUSED LOCALIZED RF HEATING AND CONTRIBUTED TO THE INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PT WAS SCANNED ON THE HITACHI OASIS OPEN MRI SYSTEM. THE EXAM WAS FOR THE CERVICAL SPINE. THE EXAM LASTED 30-40 MINS. DURING THE EXAM, THE PT INITIALLY COMPLAINED OF BEING WARM, BUT DECLINED OFFERS BY THE TECHNOLOGIST FOR A BREAK. THE TECHNOLOGIST CHECKED 3 TIMES DURING THE EXAM, EACH TIME THE PT SAID HE WAS OK. AFTER THE EXAM, THE PT WAS SWEATY AND INDICATED THAT HE WAS VERY WARM. THE PT LEFT THE FACILITY WITHOUT FURTHER COMMENT. ON (B)(6) 2011, THE PT CALLED THE MRI FACILITY TO REPORT THAT HE HAD A BURN ON HIS ABDOMEN. HE STOPPED AT THE FACILITY ON (B)(6) 2011, AND WAS EXAMINED BY THE MRI DEPT SUPERVISOR AND THE NURSING SUPERVISOR, REVEALING 2 SMALL OPEN AREAS, ONE APPROXIMATELY 8 X 5 X 2 MM WITH A YELLOW FIBROUS BASE. THESE AREAS WERE SURROUNDED BY MULTIPLE SMALL UNOPENED PINK BLOTCHES. BECAUSE OF THE PT'S SIZE, HIS STOMACH, COVERED BY HIS SHIRT, WAS TOUCHING THE UPPER MAGNET COVER DURING THE EXAM. IT IS UNK WHETHER THE INJURED AREA WAS IN CONTACT WITH THE MAGNET COVER. THE PT WENT TO HIS PRIMARY CARE DOCTOR LATER THAT DAY ((B)(6)).

    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 42 YR Required Intervention