BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARTIS DTA

    MDR report key: 16051286 · Received December 27, 2022

    Report

    Report Number
    3004977335-2022-54955
    Event Type
    Injury
    Date Received
    December 27, 2022
    Date of Event
    November 29, 2022
    Report Date
    February 13, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH-AT
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURER NARRATIVE: SIEMENS HEALTHCARE COMPLETED THE INVESTIGATION OF THE REPORTED EVENT. THE INVESTIGATION WAS PERFORMED BASED ON EXPERT DISCUSSIONS CONSIDERING THE COMPLAINT DESCRIPTION, CUSTOMER SERVICE REPORTS, SYSTEM HISTORY, AND SYSTEM LOG FILES. ACCORDING TO THE AVAILABLE EVENT INFORMATION, THE INFUSION POLE WAS PULLED AFTER IT GOT CAUGHT IN THE DISPLAY CEILING SUSPENSION (DCS) CABLES, AND AS A RESULT, A CABLE TROLLEY FELL. THE CABLE TROLLEY CANNOT FALL COMPLETELY BECAUSE IT IS STILL ATTACHED TO THE WIRING HARNESS THAT HANGS IN LOOPS FROM THE CEILING. HOWEVER, ONE STAFF MEMBER WAS HIT BY THE CARRIER, BUT WAS NOT INJURED. THE INVESTIGATION REVEALED THAT ONE (1) OF THE THREE (3) CABLE CARRIER WHEELS WAS BROKEN, WHICH CAUSED THE CARRIER SLIP OUT OF THE RAIL. THIS KIND OF ISSUE COULD OCCUR WHEN FORCES PERPENDICULAR TO THE MOVEMENT DIRECTION ARE APPLIED, AS IN THE PRESENT CASE. THE ISSUE WAS SOLVED BY REPLACING THE CABLE TROLLEY. THE OCCURRENCE RATE OF THE WAS CHECKED. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH LEADS TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE DETERMINED BY THE INVESTIGATION. H11 CORRECTED DATA: H3: DEVICE HAD NOT BEEN EVALUATED BY MANUFACTURER WHEN THE INITIAL REPORT WAS SUBMITTED ON DECEMBER 27, 2022. THIS FIELD SHOULD HAVE BEEN CHECKED "NO" IN THE INITIAL REPORT. H6: COMPONENT CODE WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF AN INCIDENT THAT INVOLVED THE AXIOM ARTIS DTA SYSTEM. WHILE TRANSPORTING A PATIENT, THE IV POLE WAS POSITIONED TOO HIGH; IT CAUGHT CABLES AND PULLED THE TROLLEY OUT OF THE TRACK. ADDITIONAL INFORMATION WAS RECEIVED THAT AN OPERATOR WAS STRUCK AS A RESULT OF THIS INCIDENT. NO FURTHER INFORMATION REGARDING HEALTH CONSEQUENCES WAS COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447510 AXIOM ARTIS DTA IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH-AT 7008605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other