BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS

    MDR report key: 2249671 · Received August 25, 2011

    Report

    Report Number
    8030405-2011-00005
    Event Type
    Other
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OASIS IS A 1.2 TESLA OPEN MAGNET. THE FLEXIBLE COIL IN USE IS A RECEIVE-ONLY RF COIL. THE COIL WAS TESTED BY HITACHI SERVICE ON (B)(6) 2011, FOR PERFORMANCE/IMAGE QUALITY AND AGAIN ON (B)(6) 2011 FOR A HEAT TEST. THE PERFORMANCE TEST DETERMINED THAT THE COIL WAS WORKING TO COMPANY SPECIFICATIONS AND THE HEAT TEST DID NOT DETECT ANY ABNORMAL SURFACE TEMPERATURE. THE COIL WAS REPLACED DUE TO A SLIGHT MECHANICAL DEFECT THAT WAS UNRELATED TO THE INCIDENT. IMAGE QUALITY OF THE EXAM WAS REPORTED TO BE LESS THAN OPTIMUM DUE TO BODY HABITUS AND PT MOTION. HITACHI CLINICAL APPLICATIONS CONCLUDED THAT THE IMAGE QUALITY WAS TYPICAL FOR THE PT SIZE AND EXAM CONDITIONS. THEREFORE, 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, IT IS CLEAR THAT THE USE OF THE MRI CONTRIBUTED TO THE EVENT IN SOME WAY.

    Description of Event or Problem · 1

    ON (B)(6), A PT WAS SCANNED ON THE HITACHI OASIS MRI SYSTEM USING AN EXTRA LARGE FLEXIBLE COIL. THE EXAM WAS FOR THE THORACIC SPINE. THE PT'S TORSO AND ARMS WERE ENCLOSED WITHIN THE COIL. THE TECH DESCRIBED IT AS A TIGHT FIT. THE PT WAS CLAUSTROPHOBIC AND WAS MILDLY SEDATED. THE PT WAS REMOVED AND RE-POSITIONED 4-5 TIMES DURING THE EXAM DUE TO MOTION. DURING THE EXAM, THE TECHNOLOGIST SWITCH THE SYSTEM TO USE THE TRANSMIT/RECEIVE BODY COIL, BUT KEPT THE PT IN FLEXIBLE COIL THROUGHOUT. AFTER THE EXAM, THE TECHNOLOGIST NOTICED BOTH ELBOWS WERE RED WHERE THEY WERE TOUCHING THE INSIDE SURFACE OF THE FLEXIBLE COIL. WHEN QUESTIONED, THE PT REPORTED THAT SHE FELT HER ARMS WERE HOT DURING THE SCAN, BUT DIDN'T REPORT IT BECAUSE SHE WANTED TO FINISH THE STUDY. THE TECHNOLOGIST THEN REPORTED A BLISTER APPROX 2 CM IN DIAMETER ON THE RIGHT ELBOW. THE PT WAS AN INPATIENT AND WAS RETURNED TO HER ROOM. A FOLLOW CALL WITH THE PT'S NURSE CONFIRMED THAT IT WAS A BURN AND THAT THE PT WAS TREATED WITH SILVADENE CREAM. THERE IS NO REPORT THAT THE OASIS SYSTEM MALFUNCTIONED AT THE TIME OF THE EXAM.

    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 41 YR Required Intervention