BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRIS II

    MDR report key: 965408 · Received December 14, 2007

    Report

    Report Number
    8030405-2007-00005
    Event Type
    Injury
    Date Received
    December 14, 2007
    Date of Event
    November 15, 2007
    Report Date
    December 14, 2007
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HITACHI MADE REPEATED UNSUCCESSFUL ATTEMPTS WITH THE SITE TO CONTACT THE PT AND DETERMINE IF THE PT'S CONDITION AND THE INITIAL CLAIM OF PERMANENT IMPAIRMENT HAD CHANGED.

    Description of Event or Problem · 1

    THE PT WAS SCANNED ON THE AIRIS II MRI SYSTEM. HIS WIFE CALLED LATER TO CLAIM HE SUFFERED PERMANENT HEARING LOSS (UNSPECIFIED SYMPTOMS). THE PT HAD A SHOULD EXAM AND WAS OFFERED HEARING PROTECTION WHICH HE INITIALLY DECLINED. AFTER THE SCAN STARTED, THE PT COMPLAINED ABOUT THE NOISE. THE TECHNOLOGIST OFFERED EARPLUGS, BUT EXPLAINED THAT SOME OF THE SCAN SEQUENCES WOULD HAVE TO BE REPEATED BECAUSE THE PT'S POSITION WOULD SHIFT WHILE INSERTING THE EARPLUGS AND WOULD INVALIDATE THE FIRST SCANS. THE PT REFUSED TO REPEAT THE SCANS, SO HE TOOK ONLY ONE PLUG ON THE SIDE OPPOSITE THE SCANNED SHOULDER. PT CAME IN THE NEXT DAY AND HAD HIS OTHER SHOULDER SCANNED. HE WAS GIVEN EARPLUGS IMMEDIATELY AND THERE WERE NO COMPLAINTS.

    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 UNK YR Other