SOMATOM DEFINITION FLASH

Description of Event or Problem

IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING A SOMATOM DEFINITION FLASH CT SYSTEM. DURING THE EXAMINATION, THE PATIENT'S BODY TOUCHED THE GANTRY COVER (SEALING RING), WHICH LED TO DEFORMATION OF THE SEALING RING. WHEN THE GANTRY STARTED TO ROTATE, THE ROTATING COMPONENTS CAME INTO CONTACT WITH THE SEALING RING, RESULTING IN DAMAGE TO THE SEALING RING AND CAUSING SKIN ABRASIONS TO THE PATIENT¿S KNEE. THE PATIENT WAS NOT FIXED DURING THE EXAMINATION. NO FURTHER DETAILS REGARDING THE PATIENT¿S AGE, GENDER, OR MEDICAL STATUS WERE PROVIDED, AS THE CUSTOMER REFUSED TO SUPPLY ADDITIONAL INFORMATION. THE REPORTED INJURY CONSISTED OF SKIN ABRASIONS AROUND THE KNEE. NO ADDITIONAL INFORMATION ON THE SEVERITY OR REQUIRED MEDICAL TREATMENT WAS PROVIDED.

Additional Manufacturer Narrative

SIEMENS HAS COMPLETED THE INVESTIGATION OF THE EVENT. THE INVESTIGATION RESULT DETERMINED THAT THIS WAS A CUSTOMER-RELATED ISSUE. THE PATIENT WAS NOT PROPERLY FIXED DURING SYSTEM MOVEMENT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) SOMATOM / SYNGO CT VA48A / PRINT NO. C2-030.620.15.03.02 / PAGE 41, THE FOLLOWING WARNING IS PROVIDED: "UNINTENTIONAL PATIENT MOVEMENT! CONTUSION OF PATIENT EXTREMITIES AT PATIENT TABLE AND GANTRY. ALWAYS FIX AND OBSERVE THE PATIENT DURING SYSTEM MOVEMENTS." FAILURE TO PROPERLY SECURE AND MONITOR THE PATIENT DURING SYSTEM MOVEMENT CAN LEAD TO UNINTENDED PATIENT MOVEMENT AND POTENTIAL INJURY. BASED ON THE AVAILABLE INFORMATION, NO SYSTEM MALFUNCTION OR DESIGN-RELATED ISSUE WAS IDENTIFIED. THEREFORE, NO FURTHER CORRECTIVE ACTIONS ARE DEEMED NECESSARY.