MULTIX TOP ACSS

Additional Manufacturer Narrative

THE ISSUE WAS INVESTIGATED IN DETAIL. THE INVESTIGATION SHOWED THAT THE DESCRIBED INSUFFICIENT IMAGE QUALITY WAS CAUSED BY A DEFECTIVE HIGH-VOLTAGE CABLE. DUE TO THE COMPLETE SEPARATION OF THE SHIELDING MESH, THE SHIELDING WAS NO LONGER FUNCTIONAL. THE PURPOSE OF THE SHIELDING MESH IS TO KEEP ELECTROMAGNETIC RADIATION FROM THE HIGH-VOLTAGE-CARRYING STRANDS IN THE HIGH-VOLTAGE CABLE FROM PENETRATING OUTSIDE INTO THE ENVIRONMENT AND TO ENSURE THE FUNCTION OF HIGH-VOLTAGE GENERATION. THIS WAS NO LONGER THE CASE AT THE AFFECTED SYSTEM AND LED TO THE DESCRIBED SIDE EFFECTS IN THE IMAGES. THEREFORE, THE IMAGES WERE ONLY PARTIALLY USABLE DUE TO ELECTROMAGNETIC INTERFERENCE AND SOME HAD TO BE REPEATED. THE REASON FOR THE DEFECT WAS THE INCORRECTLY LAID HIGH-VOLTAGE CABLE IN THE CEILING STAND ON THE X-RAY TUBE. THE LOOP IN THE CABLE WAS TOO BIG, WHICH LED TO THE CABLE BEING SQUEEZED WHEN THE TUBE WAS ROTATED. THE CAUSE OF THE ENLARGE LOOP COULD NOT BE DETERMINED. SUCH DEGRADATION OF THE CABLE DOES NOT OCCUR IN THE SHORT TERM AND IS VISIBLE FOR THE USER DURING DAILY CHECKS, WHICH ARE DESCRIBED IN THE OPERATOR MANUAL ((B)(6) PAGE 10). SERVICE MUST BE CALLED IF SUCH DEFECT IS DETECTED TO CARRY OUT A REPLACEMENT AND SYSTEM CHECK. IN THIS CASE, FOR UNKNOWN REASON THE HIGH VOLTAGE CABLE WAS REPAIRED WITH TAPE. SIEMENS HEALTHCARE IS AWARE THAT SIEMENS LOCAL SERVICE WAS NOT INVOLVED. ACCORDING TO THE AVAILABLE INFORMATION, NO PRIOR REPLACEMENT OF THE HIGH-VOLTAGE CABLE HAS OCCURRED EITHER. DETAILED EXAMINATION OF THE RETURNED DEFECTIVE CABLE SHOWED THAT THERE WERE NO TRACES OF FIRE OR DAMAGE TO THE INTERNAL INSULATION OF THE HIGH-VOLTAGE CABLE. THE ELECTRICAL CONNECTIONS IN THE CABLE WERE CHECKED AND FOUND TO BE ERROR-FREE. ACCORDING TO CURRENT KNOWLEDGE, THE BROWN COLORING OF THE CABLE MENTIONED IN THE REPORT HAS NO EFFECT ON THE FUNCTION, AS THERE HAS BEEN NO CHANGE IN THE PROPERTIES OF THE INSULATING MATERIAL. THE INVESTIGATION ALSO SHOWED THAT THERE WAS NO SAFETY RISK FOR HIGH VOLTAGE OR ELECTRICAL SHOCK TO PERSONS SINCE THE X-RAY TUBE IS GROUNDED SEPARATELY AND ALL PARTS OF THE 3D TOP WERE CONNECTED TO PROTECTIVE GROUND. IN WORST CASE IMAGE HAS TO BE REPEATED. THE SYSTEM ON SITE WAS REPAIRED AND RETURNED TO USE. INTERNAL ID # (B)(4).

Additional Manufacturer Narrative

SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE INCIDENT. THE DEFECTIVE CABLE WAS REPLACED IN THE MEANTIME, HOWEVER, THE INSTALLATION WAS PERFORMED NOT ACCORDING TO THE ORIGINAL SPECIFICATIONS. THEREFORE, THE CUSTOMER WAS REQUESTED TO NOT USE THE SYSTEM UNTIL CORRECTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID # (B)(4).

Description of Event or Problem

THE INITIAL INFORMATION REPORTED TO SIEMENS ABOUT AN ISSUE WITH THE MULTIX TOP ACCESS SYSTEM WAS ABOUT AN ERROR MESSAGE REGARDING TUBE CURRENT AND LOW IMAGE QUALITY. HOWEVER, DURING AN INVESTIGATION JULY 21, 2020, SIEMENS BECAME AWARE OF A SPARKOVER THAT OCCURRED ON THE CONCERNED DEVICE. THE SPARKOVER RESULTED IN DAMAGE OF TWO BOARDS. PROVIDED PICTURES SHOW THAT THE HV-CABLE CONNECTING THE GENERATOR WITH THE TUBE WAS DAMAGED. THE DAMAGE WAS LOCATED DIRECTLY AT THE PLUG ON THE TUBE SIDE. THE DAMAGE WAS REPAIRED WITH INSULATING TAPE; HOWEVER, THE TAPE WAS TORN AND EXPOSED THE DEFECTIVE CABLE. AT THIS POINT EXTENT OF DAMAGE TO THE CABLE IS UNCLEAR. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE EVENT OCCURRED IN (B)(6).