BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS PHENO

    MDR report key: 8482577 · Received April 4, 2019

    Report

    Report Number
    3004977335-2018-27500
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    April 24, 2018
    Report Date
    April 24, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K163286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE INVESTIGATION CONFIRMED THAT THE ERROR DESCRIBED IN THE COMPLAINT WAS THE RESULT OF A SOFTWARE BEHAVIOR. DURING MANUAL LAO/RAO ROTATION AT MAXIMUM SPEED OR A COMBINATION OF LAO/RAO AND CRAN/CAUD ROTATION AT MAXIMUM SPEED, THE POSSIBILITY EXISTS FOR THE SAFETY MONITORING WITHIN THE SYSTEM CONTROL TO BECOME ACTIVATED. AS A RESULT, THE C-ARM OF THE ARTIS PHENO STOPS THE ROTATION AND CAN DROP UP TO 40 MM (1.6"). IF THIS PROBLEM OCCURS DURING AN ONGOING PROCEDURE, THE SYSTEM PERFORMS A SAFETY STOP. AFTER THE SAFETY STOP, THE SYSTEM CAN THEN BE OPERATED NORMALLY AGAIN. UNDER CERTAIN CIRCUMSTANCES, THE COVER OF THE DETECTOR OR COLLIMATOR CAN TOUCH AND POSSIBLY INJURE THE PATIENT DUE TO THE C-ARM DROP. THIS COULD LEAD TO A SITUATION IN WHICH IT IS NECESSARY TO STOP THE CLINICAL TREATMENT OR CONTINUE THE TREATMENT ON AN ALTERNATIVE SYSTEM. SIEMENS WILL CORRECT THE ERROR BY INSPECTING ALL AFFECTED ARTIS PHENO SYSTEMS. AS AN IMMEDIATE MEASURE TO PREVENT MOVEMENT STOPS DURING A C-ARM ROTATION FOLLOWED BY A C-ARM DROP, THE MAXIMUM ROTATION SPEEDS WILL BE REDUCED. THIS CORRECTION LIMITS THE MAXIMUM MANUAL LAO/RAO ROTATION FROM 25°/SEC TO 20°/SEC AND CRAN/CAUD ROTATION FROM 20°/SEC TO 10°/SEC. THIS ACTION HAS BEEN REPORTED TO THE FDA UNDER 21 CFR 806.10: REPORT # 2240869-06/04/2018-0014.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE ROBOT STOPPED ALL MOVEMENTS. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. WHILE NO ADVERSE EVENT OCCURRED, THIS TYPE OF ERROR COULD LEAD TO THE POTENTIAL RELOCATION OF A PATIENT TO AN ALTERNATIVE SYSTEM; LEADING TO FURTHER RISK EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275604 ARTIS PHENO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10849000

    Patients

    Seq Age Sex Outcome Treatment
    1