BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRIS II MRI SCANNER

    MDR report key: 4053955 · Received July 25, 2014

    Report

    Report Number
    4053955
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    July 25, 2014
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    WHEN GETTING PATIENT UP FROM MRI OF LEFT SHOULDER, PATIENT STATED THAT HE WAS IN A LOT OF PAIN IN THE LEFT SHOULDER. PATIENT STATED IT FELT LIKE A STABBING PAIN AND LIKE IT WAS BURNING IN HIS LEFT SHOULDER. PATIENT LIFTED HIS SLEEVE AND SAID THAT HIS SHOULDER FELT COOL TO THE TOUCH. I COULD SEE THAT HIS SKIN WAS NOT RED. I CHECKED WITH THE PATIENT AGAIN BEFORE HE LEFT AND HE SAID THAT IT DID NOT FEEL LIKE IT WAS BURNING ANYMORE. THE PATIENT DID NOT HAVE ANY SKIN TOUCHING THE COIL OR THE MACHINE DURING THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437147 AIRIS II MRI SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH HITACHI MEDICAL SYSTEMS AMERICA, INC AIRIS II *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR