BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM LUMINOS DRF

    MDR report key: 13117678 · Received December 30, 2021

    Report

    Report Number
    3004977335-2021-10962
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    December 24, 2021
    Report Date
    December 30, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K062623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL. THE SAFETY DEVICE (FOC CUTOFF BAR) AT THE COLUMN, WHERE THE COMPRESSION UNIT AND ITS COVER IS MOUNTED, DOES NOT COVER THE WHOLE AREA OF THE COLUMN AND THE COMPRESSION UNIT. IT IS RESPONSIBILITY OF THE OPERATOR TO ENSURE THAT THE PATIENT IS NOT IN THE DANGER ZONE, WHICH IS NOT COVERED BY THE CUTOFF BAR. THIS IS DESCRIBED IN THE OPERATOR MANUAL XPD3-500.620.02.02.02, CHAPTER "SAFETY", PAGE 27/60. THE INVESTIGATION SHOWED THAT THE PROBLEM DESCRIPTION IS THE SAME AS THE DESCRIBED SCENARIO OF THE OPERATOR MANUAL. NO SYSTEM MALFUNCTION COULD BE DETERMINED. TO AVOID FURTHER OCCURRENCES SPECIAL ATTENTION MUST BE PAID TO THE DANGER ZONE BETWEEN THE COMPRESSION UNIT AND THE SITTING PATIENT. IT MUST BE ENSURED THAT THERE ARE NEITHER PERSONS NOR OBJECTS IN THE SWIVEL OR ROTATION RANGE OF THE MOVING PARTS OF THE SYSTEM (XPD3-500.620.02.02.02, CHAPTER DANGER ZONES, PAGE 24 FF.).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATES THAT THE SAFETY DEVICE - FOC CUTOFF BAR - WAS NOT WORKING. HOWEVER, ACCORDING TO OUR EXPERTS OPINION, IN THE DESCRIBED SITUATION THE FOC CUTOFF BAR WOULD NOT BE ABLE TO DETECT SUCH KIND OF COLLISION. AS STATED IN THE OPERATOR MANUAL, IT IS IN THE RESPONSIBILITY OF THE OPERATOR TO CHECK THE DANGEROUS ZONES DURING EXAMINATIONS/MOVEMENTS TO AVOID ANY COLLISION. TO SUPPORT THE TECHNICAL INVESTIGATION FURTHER INFORMATION WAS REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID # (B)(4).

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF AN INCIDENT ON THE AXIOM LUMINOS DRF UNIT. DURING AN EXAMINATION WITH THE TABLE TILTED TO 90° AND PATIENT SITTING ON THE FOOT REST, THE PATIENT KNEE GOT STUCK UNDER THE MOVING COMPRESSION UNIT. THE PATIENT KNEE WAS PINCHED CAUSING A SMALL MUSCULAR RUPTURE, WHICH NECESSITATED AN ULTRASOUND EXAMINATION. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019550 AXIOM LUMINOS DRF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10094200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other