BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q CEILING

    MDR report key: 10424620 · Received August 19, 2020

    Report

    Report Number
    3004977335-2020-40043
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 19, 2020
    Manufacturer
    SIEMENS HEALTHCARE GMBH- AT
    Product Code
    OWB
    UDI-DI
    04056869009988
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 A USER ERROR. THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS, SYSTEM HISTORY AND SYSTEM LOG FILES. THE COLLISION DID HAPPEN DURING USER CONTROLLED SYSTEM MOVEMENT. THE OPERATOR MANUAL CONTAINS ADEQUATE INSTRUCTIONS ABOUT SYSTEM MOVEMENT AND HOW THE OPERATOR CAN AVOID A COLLISION. THERE IS NO INDICATION FOR AN UNINTENDED MOVEMENT OF THE SYSTEM. THE COLLISION SITUATION DESCRIBED CAN OCCUR ONLY IF THE USER DOES NOT CHECK FOR COLLISIONS BEFORE RELEASING SYSTEM MOTIONS DESPITE THE OPERATOR MANUAL CONTAINING ADEQUATE INSTRUCTION ABOUT HANDLING THE SYSTEM WITH REGARDS TO THE RISK OF COLLISION. THE FOLLOWING WARNINGS / CAUTIONS ARE DESCRIBED IN THE USER MANUAL: GENERAL REMARK: OPERATOR MANUAL DOCUMENT: CHAPTER; SYSTEM OPERATION, SUB-CHAPTER: IMPORTANT INFORMATION ON UNIT MOVEMENTS: WARNING: UNIT MOVEMENTS RISK OF COLLISION, RISK OF INJURY TO PATIENT OR OPERATOR, RISK OF DAMAGE TO UNIT PARTS. - IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THAT UNIT MOVEMENTS ARE RELEASED ONLY IF IT IS CERTAIN THAT NEITHER THE OPERATOR, THE PATIENT, THIRD PARTIES NOR OTHER PIECES OF EQUIPMENT CAN BE ENDANGERED BY THESE MOVEMENTS. - ALWAYS PAY ATTENTION TO POSSIBLE COLLISIONS DURING UNIT MOVEMENTS. MAKE SURE THAT NOBODY IS STANDING INSIDE THE DANGER AREA. REMOVE ANY OBJECTS OR ACCESSORIES FROM COLLISION AREA, E.G. INJECTOR OR INFUSION STAND." AS THE OPERATOR MANUAL CONTAINS ADEQUATE INSTRUCTIONS ABOUT SYSTEM MOVEMENT AND HOW THE OPERATOR CAN AVOID A COLLISION, NO FORESEEABLE MISUSE RESULTING FROM THIS USER ERROR IS CONCERNED. THE OCCURRENCE RATE OF THE IDENTIFIED CAUSE HAS BEEN CHECKED AND NO ERROR ACCUMULATION HAS BEEN IDENTIFIED. THE OCCURRENCE RATE IS BELOW THE DEFINED THRESHOLD. THE TUBE COVER WAS EXCHANGED AND THE SYSTEM WORKS AS SPECIFIED. AFTER DETAILED INVESTIGATION, THE INCIDENT IS NOT CLASSIFIED AS A REPORTABLE EVENT AS NEITHER SERIOUS INJURY, DEATH NOR AN UNEXPECTED PROLONGED HOSPITALIZATION OF THE PATIENT OR ANY OTHER PERSON OCCURRED OR COULD BE EXPECTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. THE USER REPORTED A COLLISION BETWEEN THE X-RAY TUBE AND THE TABLE. 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 OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890252 ARTIS Q CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH- AT 10848281 04056869009988

    Patients

    Seq Age Sex Outcome Treatment
    1