BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTAIRE

    MDR report key: 1344856 · Received March 13, 2009

    Report

    Report Number
    8030405-2009-00002
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 27, 2009
    Report Date
    March 13, 2009
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K050602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACOUSTIC TEST RESULTS WERE WITHIN THE MACHINE SPECIFICATIONS. ALTAIRE USER MANUALS SPECIFY THAT HEARING PROTECTION IS REQUIRED FOR ALL PATIENTS.

    Description of Event or Problem · 1

    ON 02/27/2009, HITACHI RECEIVED A REPORT FROM A CUSTOMER WITH A HITACHI ALTAIRE MRI SYSTEM THAT ONE OF THEIR PATIENTS HAD COMPLAINED OF EXCESSIVE ACOUSTIC NOISE. THE PATIENT CLAIMED THAT THEIR EARS HURT AFTER THE PROCEDURE, AND EXPERIENCED CONSTANT BACKGROUND (WHITE) NOISE IN BOTH EARS. THE PATIENT CLAIMED A HEARING LOSS IN THE LEFT EAR. THE SITE REPORTED THAT THE PATIENT RECEIVED FOAM EARPLUGS RATED AT 37 DB OF NOISE REDUCTION, AND ALSO WAS GIVEN HEADPHONES WITH PIPED IN MUSIC. THE HEADPHONES ARE ATTACHED TO A MUSIC SYSTEM DESIGNED SPECIFICALLY FOR MRI APPLICATIONS, SO THE HEADPHONES ALSO PROVIDE SOME LEVEL OF NOISE REDUCTION OF THE MRI ACOUSTIC NOISE. THE PATIENT WAS SCANNED FOR APPROXIMATELY 30 MINUTES.

    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 UNKNOWN Disability