BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALTAIRE

    MDR report key: 1285979 · Received December 19, 2008

    Report

    Report Number
    8030405-2008-00006
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    November 24, 2008
    Report Date
    December 19, 2008
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K032232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RECEIVED COIL USED FOR THE PT EXAM WAS TESTED ON SITE AND PERFORMED ACCORDING TO SPECIFICATIONS. A HEAT TEST WAS ALSO PERFORMED TO MEASURE THE COIL SURFACE. THE SAME SCAN PROTOCOLS USED ON THE COMPLAINING PT WERE USED. HEAT TEST RESULTS NEGATIVE, SURFACE TEMPERATURE NORMAL. THE COIL WAS MECHANICALLY INSPECTED AND NO DEFECTS WERE NOTED. THE COIL WAS RETURNED TO THE HOME OFFICE FOR FURTHER TESTS. NO MALFUNCTIONS WERE DETECTED AND THE COIL PERFORMED TO SPECIFICATION. IMAGES FROM THE SITE WERE REQUESTED FOR REVIEW BUT WERE NOT PROVIDED. THE SITE DID REPORT THAT IMAGE QUALITY WAS NORMAL. THE SITE ALSO REPORTED THAT THEY CLEAN THE COIL APPROXIMATELY TWICE A MONTH. HITACHI RECOMMENDS DAILY CLEANING. HITACHI HAS REVIEWED PRIOR COMPLAINTS AND FOUND NO EVIDENCE OF BIOCOMPATIBILITY ISSUES WITH THE ALTAIRE SHOULDER COIL. THE MATERIALS USED IN THE CONSTRUCTION OF THE COIL ARE WIDELY USED IN THE MRI DEVICE INDUSTRY.

    Description of Event or Problem · 1

    A PT HAD A CERVICAL AND RIGHT SHOULDER SCAN ON (B) (6) 2008, AT A SITE USING A HITACHI ALTAIRE MRI SYSTEM WITH A SHOULDER COIL. THE PT WAS SWEATING AND HOT SO HE TOOK OFF HIS SHIRT, LEAVING ON A TANK TOP. THERE WAS DIRECT SKIN CONTACT TO THE COIL IN SOME AREAS. THE PT NEVER COMPLAINED OF ANYTHING DURING OR AFTER THE SCAN. TWO DAYS LATER ON (B) (6) 2008, THE PT CALLED THE SITE STATING THAT HIS SHOULDER LOOK LIKE HE HAD A SUNBURN AND HAD BLISTERS ON HIS RIGHT SHOULDER. THE TECHNOLOGIST THEN SPOKE TO THE SITE DOCTOR AND THEY WANTED THE PT TO COME IN TO HAVE IT LOOKED AT. THE SITE CALLED THE PT BACK ABOUT 3 HOURS AFTER THE FIRST PHONE CALL. THE PT STATED HE WENT TO HIS FAMILY DOCTOR AND THE DOCTOR SAID IT WAS PROBABLY AN ALLERGIC REACTION TO THE MATERIAL OF THE COIL AND IS BEING TREATED FOR CONTACT DERMATITIS.

    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 58 YR Required Intervention