ARTIS ZEE FLOOR

Description of Event or Problem

SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, NO X-RAY EXPOSURE WAS NOT POSSIBLE. THE PATIENT HAD TO BE RELOCATED TO A DIFFERENT MEDICAL FACILITY TO COMPLETE THE PROCEDURE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

Additional Manufacturer Narrative

SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

THE INVESTIGATION OF THE REPORTED EVENT WAS COMPLETED BY SIEMENS HEALTHINEERS. A LOCAL SIEMENS SERVICE ENGINEER WAS DISPATCHED TO THE SITE ON THE DAY FOLLOWING THE EVENT FOR TROUBLESHOOTING. UPON ARRIVAL, THE SYSTEM WAS FOUND TO BE FULLY OPERATIONAL. ANALYSIS OF THE LOG FILES FROM THE DAY OF THE EVENT INDICATED INSTABILITIES WITH THE DIGITAL IMAGE PRE-PROCESSING (DIPP) COMPONENT. HOWEVER, NOT ALL LOG FILES REQUIRED TO DETERMINE THE ROOT CAUSE WERE AVAILABLE FOR ANALYSIS. ACCORDING TO THE EXPERT OPINION, THE DESCRIBED BEHAVIOR WAS MOST LIKELY CAUSED BY A MALFUNCTION OF THE ¿FDR¿ BOARD. ACCORDING TO THE INSTRUCTIONS FOR USE, A SYSTEM SHUTDOWN AND RESTART SHOULD RESTORE SYSTEM FUNCTIONALITY IN SUCH CIRCUMSTANCES. IN THE REPORTED CASE, NO INFORMATION WHETHER THE SYSTEM HAD BEEN RESTARTED FOLLOWING THE EVENT WAS PROVIDED. THEREFORE, THIS CANNOT BE VERIFIED RETROSPECTIVELY WITHOUT DOUBT. THE OCCURRENCE RATE OF THE AFOREMENTIONED ERROR PATTERN WAS CHECKED. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH LEADS TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE DETERMINED BY THE INVESTIGATION.