BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASIS

    MDR report key: 3980636 · Received August 5, 2014

    Report

    Report Number
    8030405-2014-00008
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 9, 2014
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K072279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OASIS IS A 1.2 TESLA OPEN MRI SYSTEM. HITACHI SERVICE PERFORMED AN EVALUATION OF THE SYSTEM ON (B)(4) 2014 INCLUDING HEAT TESTS OF THE TRANSMITTER COVER. ALL TESTS WERE NEGATIVE FOR HEATING. THE SYSTEM IS OPERATING ACCORDING TO SPECIFICATIONS. THE ROOM TEMPERATURE WAS WITHIN RECOMMENDED LIMITS. HITACHI INSTRUCTIONS AND USER TRAINING INCLUDES REQUIREMENTS FOR INSULATION BETWEEN THE PATIENT'S BODY AND THE COVER (BORE) GIVEN THAT THE RF TRANSMITTER COIL IS DIRECTLY UNDERNEATH THE COVER. PROXIMITY TO THE BORE IS A KNOWN RISK FACTOR FOR RF THERMAL INJURIES. HITACHI APPLICATIONS VISITED THE SITE DURING THE WEEK OF (B)(4) AND REVIEWED THE TECHNIQUES FOR MITIGATING RF INJURIES. THERE WERE NO SYSTEM PROBLEMS DETECTED DURING THE VISIT. THE SITE DID NOT ALLOW THE REVIEW OF THE PATIENT IMAGE FILES, CITING PRIVACY CONCERNS. THE SCAN PROTOCOL USED FOR THE PATIENT HAD SAR VALUES UNDER 2.0 W/KG.

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(6) CALLED TO REPORT THAT THEY HAD RECEIVED A COMPLAINT ON (B)(6) 2014 FROM A PATIENT WHO RECEIVED A SPINE EXAM ON (B)(6) 2014. THE PATIENT WAS SCANNED ON THE HITACHI OASIS MRI SYSTEM. THE PATIENT WENT TO THE DOCTOR AFTER THE EXAM AND IS REPORTING TWO BLISTERS ON HER ABDOMEN, EACH ABOUT THE SIZE OF A DIME. THE DOCTOR TOLD HER TO USE NEOSPORIN, BUT SHE REPORTED THAT THE BLISTERS WERE NOT HEALING AND WAS PLACED ON ANTIBIOTICS. PATIENT SAID SHE FELT WARM DURING THE SCAN, BUT DIDN'T TELL ANYONE. THE PATIENT'S ABDOMEN WAS TOUCHING THE TOP TRANSMITTER, WITH ONLY A SHEET FOR SEPARATION. THE TECHNOLOGIST REVIEWED IMAGES AND DID NOT SEE ANY INDICATION OF METAL AT THE INJURY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457728 OASIS MAGNETIC RESONANCE IMAGING DEVICE LNH HITACHI MEDICAL CORPORATION OASIS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention