BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTAIRE

    MDR report key: 1942102 · Received November 12, 2010

    Report

    Report Number
    8030405-2010-00010
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K050602
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES FROM ONE CASE WHERE THE ARTIFACT OCCURRED WERE EVALUATED BY HITACHI. THE SCAN PROTOCOL PARAMETERS (MACHINE SETTINGS) USED TO CREATE THE IMAGES WERE SHOWN TO BE DIFFERENT THAN THE HITACHI RECOMMENDED SETTING FOR LUMBAR/THORACIC IMAGING. WE BELIEVE THAT THE DEVIATIONS CREATED A CONDITION THAT INCREASED THE CHANCES OF CREATING A CSF FLOW ARTIFACT. CSF FLOW ARTIFACTS ARE A COMMON PROBLEM IN MRI IMAGING, SO HITACHI, LIKE OTHER MANUFACTURERS, OPTIMIZES THE SCAN PROTOCOL PARAMETERS TO REDUCE THIS POSSIBILITY. THE PHYSIOLOGICAL VARIATIONS FROM PT TO PT CONTRIBUTED TO THE INTERMITTENT NATURE OF THE ARTIFACTS IN THIS CASE. THE SITE WAS GIVEN INSTRUCTIONS TO CHANGE THEIR PROTOCOL BACK TO THE HITACHI RECOMMENDED SETTINGS ON (B)(4) 2010 AND THE REASON FOR THE CHANGE. WE ALSO DISPATCHED AN APPLICATIONS SPECIALIST TO VISIT THE SITE ON (B)(4) 2010 TO CONFIRM THE SETTINGS AND USER UNDERSTANDING OF THE CHANGES. THE CHANGES WERE CONFIRMED ON (B)(4) 2010 BY THE HITACHI APPLICATIONS SPECIALIST WHILE ON SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DR. (B)(6), THE SITE RADIOLOGIST, REPORTED THAT ON APPROX 10% OF THE LUMBAR AND THORACIC AXIAL T2 IMAGES SCANNED ON THE HITACHI ALTAIRE MRI SYSTEM, THE CEREBRAL SPINAL FLUID (CSF) SHOWS UP DARK IN VARIOUS LOCATIONS. THE RADIOLOGIST BELIEVES THIS HAS THE POTENTIAL OF BEING MIS-INTERPRETED BY REFERRING PHYSICIANS AS A BULGING DISK AND THEREFORE COULD RESULT IN UNNECESSARY SURGERIES. THE RADIOLOGIST STATED THAT IT'S NOT A PROBLEM FOR HIMSELF IN THAT HE CAN ELIMINATE A BULGING DISK DIAGNOSIS USING THE OTHER IMAGE VIEWS IN CONJUNCTION WITH THE AXIAL IMAGES. FURTHER, DR. (B)(6) BELIEVES THAT A MIS-DIAGNOSIS OF A PT BY A REFERRING PHYSICIAN HAD OCCURRED, BUT DID NOT RECALL THE SPECIFIC EXAM OR THE DETAILS OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTAIRE MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH HITACHI MEDICAL CORP. ALTAIRE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other