BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTAIRE

    MDR report key: 2617286 · Received June 11, 2012

    Report

    Report Number
    8030405-2012-00004
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 11, 2012
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K050602
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALTAIRE IS A 0.7 TESLA OPEN MAGNET. HITACHI FIELD SERVICE INVESTIGATED THE COMPLAINT AND FOUND THAT A TRIMMER CAPACITOR HAD FAILED IN THE TRANSMITTER CIRCUIT. THE FAILED CAPACITOR WAS THE SOURCE OF THE HEAT FELT BY THE PT. THE CAPACITOR WAS REPLACED AND AFTER TESTING CONFIRMED PROPER OPERATION, THE UNIT WAS RETURNED TO SERVICE. THE COMPONENT IN QUESTION IS UNDER THE TRANSMITTER COVER, WHICH IS THE SURFACE WHERE THE PT'S ARM MADE CONTACT. THE EXACT TEMPERATURE OF THE HOT SPOT WAS NOT MEASURED, BUT HITACHI DETERMINED THAT THE MELTING POINT OF THE PAD USED IS ABOVE THE 41 DEGREE C LIMIT SET FOR PT CONTACT SURFACES PER IEC/UL 60601-1. THERE WAS NO VISIBLE DAMAGE ON THE TOP SURFACE OF THE COVER DUE TO HEAT. HITACHI HAS NOT COMPLETED THE ENGINEERING ANALYSIS OF THE CAPACITOR TO UNDERSTAND THE FAILURE MODE AND THE CHANCE OF REOCCURRENCE. NORMALLY THE EXTREMITIES REMAIN ON THE PT TABLE SURFACE, WHICH IS 80CM IN WIDTH. THE TABLETOP SLIDES OVER THE TRANSMITTER COVER AS IT ENTERS THE MAGNET. IF THE PT'S ARMS ARE UNRESTRAINED, THEY CAN MOVE OFF THE TABLE AND ON TO THE TRANSMITTER COVER. HITACHI USER TRAINING INSTRUCTS TECHNOLOGISTS TO PROVIDE PADS TO PREVENT DIRECT CONTACT WITH THE TRANSMITTER COVER DUE TO THE POTENTIAL FOR RF THERMAL INJURY FROM CLOSE PROXIMITY TO THE TRANSMIT COIL, A RISK COMMON TO ALL MRI SYSTEMS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PT WAS BEING SCANNED ON THE HITACHI ALTAIRE MRI SYSTEM. DURING THE EXAM, THE PT MOVED THEIR ARM OFF THE SIDE OF THE PT TABLE ONTO THE COVER OF THE MAGNET. THE PT REPORTED THE AREA WAS HOT TO THE TOUCH, SO THE TECHNOLOGIST PLACED AN ACCESSORY PAD UNDER THE PT'S ARM AND CONTINUED THE EXAM. AFTER THE EXAM WAS COMPLETED, WHEN THE TECHNOLOGIST REMOVED THE PAD FROM THE COVER, THERE WAS A SPOT WHERE THE PAD SURFACE WAS MELTED (APPROX 2-3CM IN DIAMETER). THIS PT WAS THE LAST OF THE DAY. THE SITE PLACED A SERVICE CALL THE NEXT MORNING AND WAS TOLD NOT TO USE THE SYSTEM UNTIL THE ISSUE WAS RESOLVED. THE PT DID NOT SUSTAIN ANY INJURY.

    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