BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRIS II

    MDR report key: 2506797 · Received March 26, 2012

    Report

    Report Number
    8030405-2012-00002
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    January 27, 2011
    Report Date
    February 29, 2012
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K974212
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AIRIS II IS A 0.3T OPEN MRI. ACOUSTIC TESTS WERE DONE ON (B)(4) 2012 USING THE SAME SCAN SEQUENCE PROTOCOLS USED ON THE COMPLAINING PT IN (B)(6) 2011. THE NOISE LEVELS WERE MEASURED AT THE SAME POSITION AS WHERE THE PT¿S HEAD WAS LOCATED DURING HER EXAM. AVERAGE ACOUSTIC NOISE MEASUREMENTS (DBA) RANGED FROM 75.1 TO 89.7 DBA. THE AVERAGE OF THE SEQUENCE WAS 82.7 DBA. PEAK NOISE RANGED FROM 75.1 TO 98.1 DB, AVERAGING 89.3 DB. THE SEQUENCE TIME AVERAGED 3 MINUTES, AND TOTAL EXAM TIME WAS APPROX 36 MINUTES. THERE ARE NORMAL PAUSES BETWEEN THE SCAN SEQUENCES, SO THE NOISE LEVELS WERE NOT CONTINUOUS. THERE WAS NO INDICATION OF A SYSTEM MALFUNCTION. THE TESTS SHOW THAT THE AIRIS II IN QUESTION OPERATES BELOW THE NORMAL OPERATING MODE THRESHOLD FOR AVERAGE AND PEAK ACOUSTIC NOISE OF 99 DBA AVERAGE, 140 DB PEAK, ESTABLISHED BY (B)(4) AND RECOGNIZED BY FDA IN THE "GUIDANCE FOR THE SUBMISSION OF PREMARKET NOTIFICATIONS FOR MAGNETIC RESONANCE DIAGNOSTIC DEVICES.¿ THE GUIDANCE STATES THAT THE ¿THE NORMAL OPERATING MODE IS CONSIDERED SAFE FOR ALL PTS, REGARDLESS OF THEIR CONDITION.¿ BASED ON THE AVAILABLE EVIDENCE, HITACHI DOES NOT BELIEVE THAT THE AIRIS II WAS THE ROOT CAUSE OF THE PT¿S ALLEGED INJURY BUT CAN NOT RULE OUT THAT IT WAS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PT RECEIVED A BRAIN EXAM ON THE HITACHI AIRIS II MRI SYSTEM. THE PT HAD TINNITUS PRIOR TO THE EXAM BEING DONE. THE PT WAS NOT GIVEN HEARING PROTECTION DURING THE EXAM. THE EXAM WAS UNEVENTFUL AND THE PT LEFT THE FACILITY WITH NO COMPLAINTS. ON (B)(6) 2011, THE PT CALLED THE FACILITY TO REPORT THAT SHE SINCE HER EXAM IN (B)(6) 2011, SHE HAS HAD CONTINUED RINGING IN HER EARS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Disability