BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRIS II

    MDR report key: 2143074 · Received June 23, 2011

    Report

    Report Number
    8030405-2011-00004
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 3, 2011
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K974212
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AIRIS II IS A 0.3T OPEN MRI WITH A 110X43CM PT OPENING. THE EXAM USED TWO RECEIVE ONLY COILS SURROUNDING THE C-SPINE AND SHOULDER AREAS RESPECTIVELY. THERE WAS NO DEVICE OR ACCESSORY IN THE VICINITY OF THE AREA WHERE THE PT CLAIMED THE INJURY. THE RF TRANSMITTER FOCUSES MOST OF ITS ENERGY TO THE MAGNET CENTER WHERE THE ANATOMY TO BE IMAGED IS POSITIONED. THE AREA WHERE THE PT CLAIMED TO BE INJURED WAS APPROX 24 INCHES FROM THE CENTER BASED ON THE PT'S HEIGHT OF (B)(6). AT THIS DISTANCE FROM THE CENTER, THE RF POWER OUTPUT IS SIGNIFICANTLY REDUCED. THERE IS NO EVIDENCE THAT THE INJURED AREA WAS IN CONTACT WITH THE TRANSMITTER COVER SURFACE. THE IMAGES OF THE PT WERE REVIEWED. NO IMAGE QUALITY OR SCAN PROTOCOL PROBLEMS WERE NOTED. THE IMAGES RECORD THE TRANSMITTER GAIN SETTING WHICH INDICATES THAT THE TRANSMITTER WAS OPERATING WITHIN NORMAL LIMITS. THE SITE INDICATED THAT THE PT WAS SCREENED FOR IMPLANTS, ETC.. THAT COULD POSE A SAFETY HAZARD TO THE PT. NONE WERE REPORTED BY THE PT. THERE WAS NO INDICATION OF A SYS MALFUNCTION. HITACHI HAD PERFORMED A ROUTINE PREVENTATIVE MAINTENANCE ON THE SYS ON (B)(6) 2011 THAT INCLUDED A CHECK OF THE RF TRANSMITTER. ALL CHECKED FUNCTIONS WERE WITHIN SPECIFICATIONS. BECAUSE THE SITE WAS NOT AWARE OF THE PT'S COMPLAINT UNTIL 6 DAYS PAST THE EVENT, THEY HAD CONTINUED TO USE THE AIRIS II WITHOUT INCIDENT AND HAD NO IMAGE QUALITY OF OTHER PROBLEMS. BASED ON THE PM AND ANALYSIS OF THE COMPLAINANT'S IMAGES, HITACHI DID NOT PERFORM ANY ADD'L FUNCTIONAL CHECKS OF THE UNIT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PT WAS SCANNED ON THE HITACHI AIRIS II MRI SYS. THE PT'S SHOULDER AND C-SPINE WERE SCANNED. THE PT WAS SCREENED FOR ANY IMPLANTS, ETC.. THAT WOULD BE CONTRAINDICATED FOR MI. THE SCANNING WAS UNEVENTFUL AND THE PT LEFT THE FACILITY WITHOUT A COMPLAINT. SCAN SEQUENCES INCLUDED SPIN ECHO, FAST SPIN ECHO, INVERSION RECOVERY AND GRADIENT ECHO. TOTAL SCAN TIME WAS APPROX 55 MINUTES. THE PT RETURNED TO THE SITE ON (B)(6) 2011 TO REPORT THAT HE HAD "HIVES AND A BLISTER" IN THE GROIN AREA (RIGHT LOWER QUADRANT). THE PT REPORTED THAT THE SYMPTOMS DID NOT BEGIN UNTIL 2 DAYS POST EXAM AND THAT HE DID NOT SEE A DOCTOR UNTIL (B)(6) 2011. THE SITE TECHNOLOGIST AND NURSE EXAMINED THE INJURED AREA AND REPORTED SEEING A BLISTER APPROX 2.5 CM IN DIAMETER BUT NO SIGN OF HIVES. THE PT'S DOCTOR REFERRED HIM TO A PLASTIC SURGEON. THE SITE WAS TOLD THAT THE PLASTIC SURGEON'S OFFICE DESCRIBED THE INJURY AS A RADIATION (SUNBURN) TYPE OF BURN, NOT A CONTACT BURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention