BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS

    MDR report key: 2426273 · Received January 17, 2012

    Report

    Report Number
    8030405-2012-00001
    Event Type
    Other
    Date Received
    January 17, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 22, 2011
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K072279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OASIS IS A 1.2 TESLA OPEN MAGNET. THE IMAGE QUALITY OF THE PT'S EXAM WAS REVIEWED AND NO PROTOCOL OR IMAGE PROBLEMS WERE NOTED OTHER THAN SOME ROUTINE FIELD OF VIEW ARTIFACTS ON MOST IMAGES THAT ARE NORMALLY ASSOCIATED WITH EDGE OF THE COIL AND FOV LIMITS (DUE TO THE PT'S SIZE). TOTAL SCAN TIME FOR THE LUMBAR EXAM WAS APPROX 27 MINUTES IN LENGTH AND 32 MINUTES IN LENGTH FOR THE THORACIC EXAM. THERE WAS VERY LITTLE PAUSE TIME BETWEEN SCANS. THE TRANSMIT/RECEIVE BODY COIL WAS USED FOR THE EXAM. THERE WERE NO OTHER COILS OR ACCESSORY DEVICES IN THE MAGNET AT THE TIME OF THE EXAM. SAR RANGED FROM A LOW OF 0.88 TO 2.24 W/KG PER SCAN SEQUENCE. SAR AVERAGED APPROX 1.6 W/KG DURING THE EXAM. THE OASIS WAS TESTED BY HITACHI ON (B)(4) 2011 AND NO MALFUNCTIONS WERE DETECTED. THE AREA OF THE TRANSMITTER COVER SURFACE WHERE THE PT'S BODY MADE CONTACT WAS TESTED FOR HOT SPOTS USING THE SCAN PROTOCOLS USED FOR THE PT. NO EXCESS HEATING WAS NOTED. IN SUMMARY, THERE IS NO INDICATION THAT THE OASIS MALFUNCTIONED AT THE TIME OF THE INCIDENT. BASED ON THE AVAILABLE EVIDENCE, HITACHI BELIEVES THAT THE ROOT CAUSE OF THE INJURY WAS THE DIRECT CONTACT OF THE PT'S ABDOMEN WITH THE TRANSMITTER COVER WITH ONLY HER CLOTHING AS AN INSULATOR. THE RF FIELD COULD HAVE INDUCED CURRENTS IN THE SKIN AND THE DIRECT CONTACT WOULD HAVE RESTRICTED AIR FLOW TO THE PT'S ABDOMEN.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PT RECEIVED A LUMBAR AND THORACIC SPINE EXAM ON THE OASIS MRI SYSTEM. DURING THE EXAM THE PT NOTICED THAT HER STOMACH WAS GETTING HOT DURING THE FIRST PROCEDURE BUT CHOSE NOT TO SAY ANYTHING. DURING THE SECOND PROCEDURE THE BURNING WAS MORE INTENSE AND SHE THEN ALERTED THE TECHNOLOGIST. THE PT STATED THAT THE TECHNOLOGIST PULLED DOWN HER PANTS AND NOTICED THAT THE AREA WAS RED. THE NEXT DAY THE PT NOTICED BLISTERS ON THE RIGHT SIDE OF THE STOMACH AND CHOSE TO SEE HER FAMILY PHYSICIAN. THE SITE MANAGER SPOKE WITH THE PT'S FAMILY PHYSICIAN WHO STATED THAT HE TREATED HER FOR A SECOND DEGREE BURN ABOUT THE SIZE OF A GOLF BALL ON HER LOWER ABDOMEN. THE PHYSICIAN EQUATED THE BURN SEVERITY TO A BAD SUNBURN. THE PT'S ABDOMEN WAS CONTACTING THE UPPER TRANSMITTER COVER OF THE OASIS AND THERE WAS NO INSULATING MATERIAL USED BETWEEN THE COVER AND THE PT'S BODY OTHER THAN HER CLOTHING. THE PT REPORTED THE INJURY TO THE MRI FACILITY ON (B)(6) 2011.

    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 48 YR Other