BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARISTOS MX/VX

    MDR report key: 11176776 · Received January 15, 2021

    Report

    Report Number
    3002808157-2021-61949
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 15, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    KPR
    PMA / PMN Number
    K061054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL. ACCORDING TO THE SUBMITTED INFORMATION, AN EXAMINATION WAS CARRIED OUT ON A PATIENT (CHILD) AND THE LASER WAS NOT PLACED DIRECTLY ON PATIENT'S EYES. THE PATIENT WAS LYING ON HER BACK AND THE X-RAY TUBE WAS COMING FROM THE SIDE ABOUT 50 OR MORE INCHES AWAY. IT WAS AIMED FROM HER EAR/CHIN DOWN TO HER HIPS. ONCE MEDICAL STAFF LEFT THE ROOM TO DEVELOP THE IMAGE, THE PATIENT MAY HAVE MOVED DOWN THE TABLE AND TURNED HER HEAD TOWARDS THE LASER. IN SUCH SITUATIONS THE OPERATOR MUST CLOSE THE SLIDING COVER OF THE LASER BEAM EXIT BEFORE LEAVING THE PATIENT ON THE TREATMENT TABLE. THE USER MANUAL AND THE SAFETY NOTICE ON THE SYSTEM REFERS TO A CLASS 2 LASER, WHICH USES VISIBLE LIGHT. THE OUTPUT OF THIS LASER DOES NOT PRODUCE ENOUGH INTENSITY TO CAUSE INJURY TO PERSONS UNDER NORMAL CIRCUMSTANCES. CLASS 2 LASER WAVELENGTH RANGES BETWEEN 400 NM AND 700 NM AND HAS A PEAK-POWER OF 1 MILLIWATT OR LESS. THE LASER RADIATION IS HARMLESS, EVEN IF THE EYES ARE IRRADIATED FOR A SHORT TIME. PROLONGED IRRADIATION OF THE EYES IS PREVENTED BY THE SO-CALLED NATURAL EYELID CLOSURE REFLEX. THIS BLINKING REFLEX (CLOSED EYE LIDS) PREVENTS PERSONS FROM DAMAGE. THEREFORE, THIS TYPE OF LASER IS SAFE. HOWEVER, THERE IS ONE EXCEPTION: THE BLINKING REFLEX CAN BE SUSPENDED BY DRUG USAGE OR WILLFUL STARING INTO THE BEAM. IT IS OPERATOR'S RESPONSIBILITY TO PREVENT THE DESCRIBED SITUATION AND ENSURE PATIENT SAFETY. TO MAKE IT EASY FOR THE OPERATOR, THE SLIDING COVER OF THE LASER BEAM EXIT CAN BE CLOSED MANUALLY. THIS IS STATED IN THE USER MANUAL (AXB4-210.620.06.02.02, PAGE 20, 52, 84 AND 18 ACCESSORIES); FURTHERMORE, SUCH CAUTION LABEL IS ATTACHED TO THE DEVICE NEXT TO THE LASER RADIATION EXIT. THE OPTICAL OUTPUT POWER OF THE USED LINE LASER LD650 IS BELOW THE SPECIFIED ALLOWED MAXIMUM OUTPUT POWER FOR CLASS 2 LASER. WITH THIS POWER, NO INJURY TO THE EYE OR SKIN IS TO BE EXPECTED EVEN WHEN LOOKING INTO OR BEING EXPOSED TO THE LASER BEAM FOR LONGER PERIODS OF TIME. NEVERTHELESS, THE USER SHOULD ENSURE THAT THE PATIENT DOES NOT STARE INTO THE LASER FOR EXTENDED PERIODS OF TIME. IN APRIL 2012, THE ENTIRE COLLIMATOR (INCLUDING THE LASER) WAS REPLACED AT THIS CUSTOMER SITE. IT IS ENSURED THAT THE CORRECT LASER IS INSTALLED IN THE COLLIMATOR.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. THE CONCERNED LASER WAS REQUESTED FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID # PM00261949.

    Description of Event or Problem · 1

    DECEMBER 28, 2020 SIEMENS WAS INFORMED ABOUT AN INCIDENT ON THE AXIOM ARISTOS MX / VX UNIT. PATIENT'S FATHER COMPLAINED THAT HIS DAUGHTER'S EYE WAS DAMAGED BY THE LOCALIZING LASER. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED LATER, A KERATITIS WAS DIAGNOSED BY THE FAMILY OPHTHALMOLOGIST. ADDITIONAL INFORMATION WAS REQUESTED TO PROCEED WITH INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76860 AXIOM ARISTOS MX/VX STATIONARY X-RAY SYSTEM KPR SIEMENS HEALTHCARE GMBH 5895003

    Patients

    Seq Age Sex Outcome Treatment
    1