BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS

    MDR report key: 2556490 · Received April 27, 2012

    Report

    Report Number
    8030405-2012-00003
    Event Type
    Other
    Date Received
    April 27, 2012
    Date of Event
    February 28, 2012
    Report Date
    April 9, 2012
    Manufacturer
    HITACHI MEDICAL CORP
    Product Code
    LNH
    PMA / PMN Number
    K072279
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OASIS IS A 1.2 TESLA OPEN MAGNET. BECAUSE THE SITE HAD DETERMINED THERE WAS NO REPORTABLE ISSUE, THEY HAD CONTINUED TO USE THE SYS AND COIL ROUTINELY AFTER (B)(4) 2012, AND HAD NO OTHER COMPLAINTS. IMAGE QUALITY WAS NORMAL. HITACHI TESTED THE CTL RECEIVE COIL USED FOR THE PT STUDY, INCLUDING MEASURING THE SURFACE FOR HEATING USING THE SAME SCAN PROTOCOLS USED ON THE PT'S EXAM. THE SURFACE TEMP DID NOT EXCEED 77 DEGREES FAHRENHEIT. HITACHI CLINICAL SCIENCE REVIEWED THE PT'S IMAGES AND DID NOT FIND ANY PROTOCOL ISSUES OR IMAGE PROBLEMS INDICATING THAT THE SYS HAD MALFUNCTIONED. THE REPORT DID NOTE THAT THE PT'S EXAM LASTED APPROX 97 MINUTES AND THERE WAS NO PAUSES WITHIN EACH EXAM SEGMENT, ONLY BETWEEN SEGMENTS AS NOTED IN SECTION B5. ESTIMATED SAR LEVELS AVERAGED AROUND 2 W/KG, BUT THERE WAS ONE SEQUENCE THAT REGISTERED 3.93 W/KG THAT WAS 5:21 MINUTES IN LENGTH DURING THE LATTER PART OF THE THORACIC EXAM. THE EXAMINING RADIOLOGIST SPECULATED THAT THE SKIN REDNESS MAY HAVE BEEN CAUSED BY A SKIN FOLD THAT ALLOWED AN RF CURRENT LOOP, BUT THERE IS NO DIRECT EVIDENCE TO SUPPORT THAT IDEA. HITACHI CANNOT DETERMINE A DIRECT ROOT CAUSE BUT THE LENGTH OF THE EXAM COUPLED WITH A PERIOD OF HIGH SAR COULD HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PT RECEIVED A SPINE EXAM ON A HITACHI OASIS MRI SYS. THE PT WAS SCANNED IN STREET CLOTHES (BRA REMOVED) AND WAS GIVEN THE USUAL PRE SCREENING FOR MRI CONTRAINDICATIONS. THE PT WAS PLACED ON THE PADDED SPINE RECEIVE COIL AND HAD A CALL BUTTON AVAILABLE TO NOTIFY THE TECHNOLOGIST OF ANY PROBLEMS. THE FIRST PHASE OF THE EXAM WAS FOR THE C-SPINE. AFTER IT COMPLETED, THE PT WAS EXTRACTED FROM THE MAGNET, BUT DID NOT MOVE FROM THE COIL. NEXT, THE THORACIC SPINE WAS IMAGED. AFTERWARDS, THE PT ASKED TO GO TO THE RESTROOM AND COMPLAINED HER BACK WAS HURTING A LITTLE BIT AND THAT SHE'D BEEN LYING DOWN TOO LONG. SHE CHOSE TO CONTINUE AND FINISH THE LUMBAR PORTION OF THE EXAM AND STATED HER BACK WAS SORE AFTERWARDS. THE NEXT MORNING ((B)(6)), THE PT CALLED TO REPORT REDNESS ON HER BACK. SHE RETURNED TO THE SITE AND WAS EXAMINED BY A RADIOLOGIST THAT NOTED A FOCAL ERYTHEMATOUS PATCH (6 CM X 1.5 CM) ON HER SKIN OVER THE LOWER THORACIC SPINE EXTENDING ACROSS THE MIDLINE. THERE WAS NO BLISTERING OR WEEPING OF THE SKIN. THE RADIOLOGIST RECOMMENDED THE TREATMENT WITH IBUPROFEN AND A TOPICAL ANESTHETIC. THE PT RETURNED ON (B)(6) FOR A F/U EXAM. THE SKIN ERYTHEMA WAS MUCH IMPROVED, MUCH SMALLER AND HAD FADED SIGNIFICANTLY WITH NO PAIN. THE RADIOLOGIST FELT THE INJURY WAS RESOLVING AND DID NOT REQUIRE ADD'L F/U UNLESS CONDITIONS CHANGED. THE SITE DID NOT BELIEVE THE INJURY TO BE REPORTABLE AND CLOSED THE CASE. THERE WAS NO REPORTED IMAGE QUALITY ISSUES WITH THE EXAM AND NO INDICATION OF A MALFUNCTION AT THE TIME. ON 4/9/2012, THE SITE NOTIFIED HITACHI OF THE EVENT FOLLOWING RECEIPT OF A LETTER FROM THE PT'S DAUGHTER COMPLAINING ABOUT THE INCIDENT. THE LETTER DID NOT INDICATE THAT THE PT HAD SUFFERED ANY FURTHER PROBLEMS, BUT WAS CONCERNED ABOUT UNK FUTURE EFFECTS.

    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 73 YR Other