BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTITOM RAX

    MDR report key: 12306681 · Received August 11, 2021

    Report

    Report Number
    3004977335-2021-91969
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 11, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    UDI-DI
    04056869009179
    PMA / PMN Number
    K152928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL. ACCORDING TO THE INFORMATION RECEIVED, THERE WAS AN UNINTENDED MOVEMENT OF THE TUBE STAND WITHOUT OPERATOR INPUT. IT WAS COMMUNICATED THAT AS SOON AS THE PATIENT WAS SELECTED ON THE FLC, THE SYSTEM MOVED TO WALL POSITIONING, EVEN THOUGH THE SELECTED EXAMINATION AND THE CORRESPONDING ORGAN PROGRAMS DID NOT INCLUDE ANY WALL POSITIONING. THE ISSUE OCCURRED TWICE WITH THE CONCERNED UNIT. THERE WAS NO CONTACT OR COLLISION BETWEEN THE MOVING SYSTEM AND ANY PERSON PRESENT IN THE ROOM. THE INVESTIGATION OF THE LOG FILES SHOWED THAT THE OGP SWITCH ON THE KICK FOOT BAR WAS PRESSED IN BOTH CASES. THE ACTIVATION OF THE OGP SWITCH ON THE KICK FOOT BAR CAN MOVE THE 3D TUBE STAND TO WALL POSITIONING, FOR EXAMPLE FOR CENTERING, EVEN IN CASES WHERE WALL POSITIONING IS NOT PART OF THE EXAM. SIEMENS LOCAL SERVICE TECHNICIAN INSPECTED THE SYSTEM AT CUSTOMER SITE BUT WAS UNABLE TO IDENTIFY EITHER ANY DEFECT IN THE KICK FOOT BAR OR SYSTEM MALFUNCTION. THE LOCAL SERVICE TECHNICIAN MADE THE CUSTOMER AWARE OF THE NEED TO ENSURE THAT NO ONE INADVERTENTLY ACTIVATES A SWITCH IN THE FUTURE AS AN UNINTENTIONAL ACTIVATION OF THE KICK FOOT BAR COULD CAUSE THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    SIEMENS LOCAL SERVICE ENGINEER INSPECTED THE INVOLVED UNIT AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. ACCORDING TO THE ENGINEER, THE SYSTEM WORKS AS SPECIFIED. THE SYSTEM IS EQUIPPED WITH EMERGENCY STOP BUTTON TO PREVENT ALL UNWANTED SYSTEM MOVEMENT. THERE IS A COLLISION ZONE AROUND THE PATIENT TABLE TO PREVENT THE MOVING TUBE STAND FROM HITTING A PATIENT POSITIONED ON THE TABLE. IT IS CURRENTLY UNCLEAR WHERE THE PATIENT WAS POSITIONED AT THE TIME OF THE EVENT. THE FORCE OF THE OVERHEAD TUBE IS LIMITED. THEREFORE, IT IS ASSUMED THAT ONLY A MINOR TO MODERATE INJURY MIGHT OCCUR IF A PERSON WERE TO BE HIT UNDER NORMAL CIRCUMSTANCES. THE CAUSE FOR THE ISSUE UNCLEAR AND THE INVESTIGATION IS ON-GOING. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. INTERNAL ID # (B)(4).

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF UNINTENDED SYSTEM MOVEMENT OF THE MULTITOM RAX DEVICE. THE 3D TUBE STAND MOVED TO POSITION WITHOUT GIVEN COMMAND. THE USER WAS PREPARING FOR A PATIENT EXAM; WHEN THE EXAM WAS OPENED ON THE FLC, THE TUBE STAND IMMEDIATELY STARTED MOVING AND ALIGNED ITSELF TO A WALL STAND OGP (ORGAN PROGRAM) POSITION, THOUGH, THE EXAMINATION WAS WRIST COMPLETE. NONE OF THE OGPS IN THIS EXAM INCLUDED WALL POSITIONS. THE REPORTED ISSUE OCCURRED TWICE. FOLLOWING THE FIRST OCCURRENCE, THE SYSTEM LOCKED UP IN A WALL POSITION; THE USER HAD TO REBOOT TO ATTEMPT THE EXAMINATION AGAIN. DURING THE SECOND ATTEMPT, THE SYSTEM MOVED TO A WALL POSITION AGAIN ONCE THE EXAM WAS OPENED, HOWEVER, THE UNIT DID NOT LOCK UP AND THE OPERATOR WAS ABLE TO MOVE THE TUBE STAND MANUALLY TO THE CORRECT POSITION AND COMPLETE THE EXAM. THE OVERHEAD TUBE AVOIDED PATIENT CONTACT WHILE IN MOTION. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207020 MULTITOM RAX IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10860700 04056869009179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other