BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS

    MDR report key: 3926155 · Received July 10, 2014

    Report

    Report Number
    8030405-2014-00006
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K072279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTS OF THE COIL ON SITE ON (B)(6) 2014 DID NOT REVEAL ANY HEATING. TESTS AT HITACHI ON (B)(6) 2014 SHOWED THAT IN CERTAIN POSITIONS WHEN OFFSET FROM THE MAGNET CENTERLINE, THE COIL POSTERIOR SURFACE AND THE CABLE BALUN EXCEEDED 41° C (IEC 60601-1 LIMIT). TESTS OF THE SAME MODEL COIL FROM ANOTHER SYSTEM SHOWED NO SIMILAR HEATING, SO THE SUSPECT COIL APPEARS TO HAVE SOME DEFECT. HOWEVER, INITIAL BENCH AND IMAGE QUALITY TESTS OF THE SUSPECT COIL SHOWED NORMAL PERFORMANCE. THERE WERE NO IMAGE QUALITY PROBLEMS NOTED BY THE CUSTOMER. FURTHER SYSTEM TESTING TO DISCOVER THE ROOT CAUSE OF THE COIL HEATING WERE INCONCLUSIVE. THE COIL IS BEING SENT TO JAPAN FOR FURTHER ANALYSIS. NO OTHER SITE HAS REPORTED A SIMILAR PROBLEM.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AFTER THE COMPLETION OF A LUMBAR EXAM ON THE HITACHI OASIS MRI SYSTEM, THE TECHNOLOGIST NOTICED THAT A SECTION OF THE RAPID BODY COIL (RBC) CONNECTOR CABLE CALLED THE BALUN APPEARED TO HAVE MELTED DUE TO HIGH TEMPERATURE. THE BALUN WAS NOT WARM AT THE TIME AND GAVE OFF NO ODOR. THE COIL ITSELF WAS NOT WARM AND PREFORMED NORMALLY. THE SITE HAD NO IDEA HOW LONG AGO OR UNDER WHAT CIRCUMSTANCES THE CABLE DAMAGE OCCURRED. THE EXAM IMAGE QUALITY WAS NORMAL AND THE PATIENT WAS UNHARMED. HITACHI DIRECTED THE CUSTOMER TO TAKE THE COIL OUT OF SERVICE UNTIL IT COULD BE TESTED. IT WAS LATER REPLACED AND RETURNED TO HITACHI AFTER ON-SITE TESTING WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403579 OASIS MAGNETIC RESONANCE IMAGING DEVICE LNH HITACHI MEDICAL CORPORATION OASIS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1