BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q BIPLANE

    MDR report key: 8173224 · Received December 18, 2018

    Report

    Report Number
    3004977335-2018-50430
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 9, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K123529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE THE COMBINATION OF A SOFTWARE ERROR OF THE STAND CONTROL UNIT (SCU) IN CORRELATION WITH THE NEW MOTOR CONTROL UNIT. THE INVESTIGATION SHOWED THAT THE ERROR DESCRIBED IN THE COMPLAINT WAS CAUSED BY A COMBINATION OF SOFTWARE ERROR OF THE STAND CONTROL UNIT (SCU) IN CORRELATION WITH THE NEW MOTOR CONTROL UNIT (MCM4), WHICH WAS INTRODUCED IN MAY 2018. THE ERROR OCCURS AFTER A SYSTEM COLLISION AND THE COLLISION SAFETY SWITCH OF THE FD-GUARD REMAINS ACTIVE BECAUSE THE SYSTEM STAYS IN THAT POSITION. IN THIS CASE THE MAGNETIC TABLE RELEASE REMAINED LOCKED AND THE PATIENT TABLE IS NOT FLOATABLE. THE ERROR CAN BE RESOLVED WHEN THE OPERATOR MOVES THE SYSTEM OUT OF THE COLLISION ZONE IN OVERRIDE MODE OR BY USING OTHER DEFINED RESCUE PROCEDURES. THIS IS WELL DESCRIBED IN THE INSTRUCTIONS FOR USE. THE SYSTEM WAS CHECKED BY A SIEMENS SERVICE ENGINEER; HOWEVER, A FINAL SOLUTION IS NOT CURRENTLY AVAILABLE. A CORRECTIVE MEASURE IS PLANNED TO BE RELEASED FOR Q2/2019 WITH UPDATE AX045/18/S. THIS ACTION WILL BE REPORTED TO THE FDA UNDER 21 CFR 806.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO TABLE MOVEMENTS WERE POSSIBLE IN OVERRIDE MODE. THE ERROR OCCURRED WHILE THE PHYSICIAN WAS ATTEMPTING TO RESCUE THE PATIENT. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012032 ARTIS Q BIPLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10848282

    Patients

    Seq Age Sex Outcome Treatment
    1