BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEEGO

    MDR report key: 8482678 · Received April 4, 2019

    Report

    Report Number
    3004977335-2019-63825
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    January 5, 2019
    Report Date
    January 7, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K141574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT OF THE LOG FILES DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. THE LOG FILE ANALYSIS SHOWED A HIGH LOAD AT THE CENTRAL PROCESSING UNIT (CPU) WHICH DISTURBS THE ROBOT COMMUNICATION. AS A RESULT, THE ROBOT PERFORMS A SAFETY STOP IN WHICH THE MOTOR IS SWITCHED OFF AND THE BRAKES ARE APPLIED. DURING THE DELAY BETWEEN SWITCHING OFF THE MOTORS AND ACTIVATING THE BRAKES, THE ROBOT MAY DROP A MAXIMUM OF 5 CM DUE TO GRAVITATIONAL FORCE. THIS IS NORMAL SYSTEM BEHAVIOR WHICH ALWAYS OCCURS WHEN THE ROBOT GOES TO SAFETY STOP, E.G. WHEN A PROXIMITY SWITCH IS ACTIVATED. THIS BRAKING REACTION IN THE DESIGNATED MOVEMENT PATH RESULTS IN THE SHAKING OF THE C-ARM WITH DEFLECTION OF A FEW MM AND MAY HAVE GIVEN THE IMPRESSION OF A DROP TO THE USER. AFTER THE RESTART OF THE SYSTEM THE MOVABILITY WAS RESTORED. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT AS NO SYSTEMATIC ERROR HAS BEEN RECOGNIZED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THIS EVENT OCCURRED IN (B)(6). RESUBMISSION OF INITIAL REPORT DUE TO REPORT CODE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING A PATIENT EXAMINATION, THE USER REPORTED THAT THE SYSTEM DROPPED A FEW CENTIMETERS. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278187 ARTIS ZEEGO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10280959

    Patients

    Seq Age Sex Outcome Treatment
    1