BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRIS ELITE

    MDR report key: 3909653 · Received July 2, 2014

    Report

    Report Number
    8030405-2014-00005
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    06/04/14
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HMSA EXAMINED THE SERVICE RECORDS FROM THE 2011 INCIDENT AND NOTED THAT THE SYSTEM RADIO FREQUENCY POWER AMPLIFIER (RFPA) THAT DRIVES THE RF SIGNAL TRANSMITTER WAS AT FAULT AND WAS REPLACED. HMSA SERVICE EXAMINED THE TRANSMITTER SYSTEM AND FOUND THAT IT WAS OUT OF CALIBRATION. IT SHOULD BE NOTED THAT THE THE IMAGE QUALITY OF ALL OTHER STUDY TYPES WAS NORMAL AND ONLY THE IAC IMAGES WERE AFFECTED. CLINICAL APPLICATIONS WAS ON SITE ON (B)(6) 2014 TO CHECK THE SYSTEM SCAN PROTOCOLS AND USER PROCEDURES. ALL PROCEDURES AND PROTOCOLS WERE WITHIN NORMAL CONDITIONS. SERVICE TRIED A NEW RFPA AND A HEAD COIL, BUT NEITHER RESOLVED THE PROBLEM, SO THE ORIGINAL PARTS WERE RE-INSTALLED. SERVICE THEN RECALIBRATED THE TRANSMITTER SUB-SYSTEM AND WAS ABLE TO RESOLVE THE ISSUE. HOWEVER, WE HAVE NOT RECEIVED CONFIRMATION FROM THE SITE AS THE RADIOLOGIST IS ON VACATION UNTIL MID-JULY. IF THE SITE DOESN'T AGREE THAT THE ARTIFACT IS RESOLVED, HITACHI WILL INVESTIGATE FURTHER AND FILE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    HITACHI MEDICAL SYSTEMS AMERICA INC. (HMSA) RECEIVED A REPORT FROM A U.S. CUSTOMER ON (B)(4) 2014. THEY HAD SCANNED A PATIENT USING A HITACHI AIRIS ELITE MRI SYSTEM AND CALLED TO COMPLAIN ABOUT IMAGE QUALITY. THE SITE SENT HMSA IMAGES FOR REVIEW. THE PATIENT STUDY INCLUDING IMAGES OF THE INNER AUDITORY CANAL (IAC), AND THE RADIOLOGIST COMPLAINED OF ARTIFACTS THAT MIMIC THE CONDITION SUPERFICIAL SIDEROSIS. THE RADIOLOGIST REPORTED THAT THE SAME ARTIFACT HAD OCCURRED ONCE BEFORE IN 2011. AT THAT TIME, HE HAD REPORTED THE PATIENT TO HAVE THE CONDITION, BUT LATER CHANGED HIS DIAGNOSIS WHEN ANOTHER PATIENT'S IMAGES SHOWED THE SAME INDICATIONS. THE SITE HAD CALLED FOR SERVICE, BUT DID NOT REPORT THE MISDIAGNOSIS AT THAT TIME. IN THE RECENT CASE, THE RADIOLOGIST IMMEDIATELY DETERMINED THAT AN ARTIFACT EXISTED AND NOTIFIED HITACHI FOR SERVICE. DURING FACT FINDING ON (B)(6) 2014, HMSA LEARNED OF THE 2011 MISDIAGNOSIS. NEITHER THE 2011 CASE OR THE CURRENT CASE RESULTED IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386560 AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE LNH HITACHI MEDICAL CORPORATION AIRIS ELITE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1