BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTITOM RAX

    MDR report key: 6331893 · Received February 15, 2017

    Report

    Report Number
    2240869-2017-00829
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 27, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K152928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCORRECT INFORMATION WAS ENTERED IN THE FOLLOW-UP REPORT VERSION 1 AND THE NARRATIVE IS NOT ASSOCIATED WITH THE REPORTED EVENT. PLEASE SEE THE CORRECT NARRATIVE BELOW. THE REPORTED ISSUE WAS INVESTIGATED IN DETAIL. THE INVESTIGATION SHOWED THAT THE DESCRIBED BEHAVIOR WAS CAUSED BY TO A SOFTWARE ERROR IN COMBINATION WITH A SPECIAL WORKFLOW, WHEN THE SYSTEM TRIES TO COMPENSATE A SID-DIFFERENCE (SOURCE-IMAGE-DISTANCE). THE HAND GRIPS AT THE DETECTOR STAND AUTOMATICALLY RETRACT BEFORE AN (AUTOMATIC) MOVEMENT STARTS. THE FOLLOWING PRECONDITIONS WERE DETERMINED WHICH LEAD TO THE DESCRIBED BEHAVIOR: THE HANDGRIPS ARE EXTENDED. THE CUSTOMER PRESSES A BUTTON E.G. "MOVE TO OGP POSITION". THE HANDGRIPS START TO RETRACT; THE SYSTEM DOES NOT OTHERWISE MOVE AND WAITS UNTIL THE HANDGRIPS ARE RETRACTED BEFORE THE HANDGRIPS HAVE BEEN COMPLETELY RETRACTED, THE CUSTOMER RELEASES THE "MOVE TO OGP POSITION" BUTTON AND PRESSES IT AGAIN. THESE PRECONDITIONS CAUSED THE MOVEMENT COMMAND TO THE HAND GRIPS TO "HANG" IN THE SOFTWARE. THE SYSTEM IS FULLY OPERATIONAL AT THE CUSTOMER SITE AND THERE ARE NO LIMITATIONS TO THE UNIT'S FUNCTIONS UNLESS THE FOLLOWING WORKFLOW IS PERFORMED: SWITCH TO EXAMINATION MODE, SELECT AN OGP WITH SID TRACKING, CENTER TUBE TO DETECTOR (SID TRACKING IS ACTIVE), SWITCH TO PATIENT MODE, CHANGE THE SID (E.G. FROM 115CM TO 100CM), SWITCH TO EXAMINATION MODE, SELECT AGAIN THE OGP WITH SID TRACKING (TUBE IS STILL CENTERED TO THE DETECTOR). IF THE DESCRIBED ABOVE WORKFLOW IS FOLLOWED, THE DESCRIBED ISSUES MAY OCCUR. HOWEVER, SEVERAL WORKAROUNDS ARE AVAILABLE TO AVOID THIS BEHAVIOR. THE REPORTED ISSUE WILL BE RESOLVED WITH A SOFTWARE UPDATE VERSION VE30B WHICH IS PLANNED TO BE RELEASED FOR THE INSTALLED BASE IN Q3/ 2017.

    Additional Manufacturer Narrative · 1

    THE AFFECTED MONITORS WITH PROTECTIVE COVER WERE REQUESTED FOR FURTHER INVESTIGATION, HOWEVER, ONLY THE PROTECTIVE COVER WAS PROVIDED. THE METAL STRIPS WERE SENT TO THE FACTORY FOR THE INVESTIGATION AS WELL, HOWEVER, THEY HAVE NOT ARRIVED. ACCORDING TO THE PROVIDED PHOTOS FROM THE CUSTOMER SITE, BOTH STRIPS ON THE MONITOR WERE CURVED. DUE TO THIS THE MAGNETIC ADHESION WAS VERY LIMITED. THE PRODUCTION LINE WAS CHECKED; THE MATERIAL TESTING LAB AND THE SUPPLIER INVESTIGATED THIS ISSUE AS WELL. ALL THESE ACTIONS COULD NOT CONFIRM ANY MALFUNCTION. THE ISSUE WAS NEITHER CAUSED BY A MANUFACTURING DEFECT NOR AN ASSEMBLY ERROR NOR BY EXTERNAL INFLUENCES SUCH AS CLEANING AGENT, HUMIDITY OR TEMPERATURE. IT IS ASSUMED THAT ONLY THE FOLLOWING WORKFLOW COULD HAVE CAUSED THIS ISSUE: THE AFFECTED STRIPS WERE LOCALLY PEELED OFF BOTH AFFECTED STRIPS. THEREFORE, THE STRIPS GOT BENT. AS THEY WERE LATER REATTACHED, THIS STRONGLY REDUCED THE MAGNETIC ADHESION OF THE PROTECTIVE COVER. THE INVESTIGATION OF THE RETURNED PROTECTIVE COVER SHOWED A SMALL CRACK WHICH WAS PROBABLY CAUSED BY THE DESCRIBED FALL. THE CHECK OF THE ACTUAL MANUFACTURING DOCUMENTS ((B)(4)) SHOWED THAT A HINT IS AVAILABLE. IT STATES THAT AFTER AFFIXING, THE COVER MAY NOT BE MOVED FOR FOUR HOURS TO ENSURE DRYING AND HARDENING OF THE GLUE. A FURTHER HINT (WITHIN THE MANUFACTURING DOCUMENTATION) STATES THAT THE FIXED METAL STRIPS MAY ONLY BE USED ONCE. THIS HINT IS PLANNED TO BE ADDED TO THE CUSTOMER SERVICE DOCUMENTATION. FURTHERMORE, ANOTHER HINT WITHIN THE SERVICE DOCUMENTATION ("REPLACEMENT OF PARTS - TD00-000.841.37.03.02") IS PLANNED TO BE ADDED STATING THAT IN CASE OF REPLACEMENT OF THE MONITOR MRDC-1119 (10594707) A PROTECTIVE COVER MUST ALSO BE ORDERED AND THE METAL STRIPS MAY ONLY BE USED ONCE. THE PROTECTIVE COVER WAS REPLACED AT THE FACILITY. THE SPARE PART CONSUMPTION OF THE AFFECTED PROTECTIVE COVER WAS CHECKED AND SHOWS NORMAL VALUES BELOW THRESHOLD.

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS EQUIPPED WITH RED EMERGENCY BUTTON TO ALL SYSTEM MOVEMENT. BOTH PARTS (DETECTOR AND X-RAY TUBE) ARE EQUIPPED WITH FRICTION BRAKES AT 200N. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE CUSTOMER'S ADDRESS: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNINTENDED SYSTEM MOVEMENT OCCURRED WHILE POSITIONING PATIENT FOR AN EXAMINATION OF LEFT HAND ON THE MULTITOM RAX UNIT. THE PATIENT WAS SEATING WITH AN ARM ON THE DETECTOR. WHEN THE OPERATOR PUSHED A BUTTON TO RAISE THE DETECTOR UP, THE DETECTOR KEPT MOVING UP EVEN AFTER THE BUTTON WAS RELEASED. AT THE SAME TIME THE X-RAY TUBE STARTED TO MOVE DOWN FOR UNKNOWN REASONS. THE OPERATOR PANICKED AND USED HER HANDS TO STOP THE DETECTOR FROM CRUSHING PATIENT'S HAND. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115341 MULTITOM RAX IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM. OWB SIEMENS HEALTHCARE GMBH 10860700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other