INNOVA IGS 520 OMEGA

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE FRANCE BUC YVELINES, 78530. D4: UDI NOT REQUIRED AS DEVICE MANUFACTURED PRIOR TO UDI IMPLEMENTATION.

Description of Event or Problem

A CUSTOMER REPORTED THAT GE HEALTHCARE VASCULAR SYSTEM LEAD CURTAINS FELL DURING AN INTERVENTION, NO INJURY HAS BEEN REPORTED. IT HAS BEEN REPORTED THAT THE GUIDE RAIL NEXT TO THE BED BROKE CAUSING THE SHIELD TO FALL. GE HEALTHCARE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

GE HEALTHCARE HAS CONCLUDED ITS INVESTIGATION INTO THE REPORTED INCIDENT. NO INJURIES WERE REPORTED; HOWEVER, THE POSSIBILITY OF THE RADIATION SHIELD DETACHING AND CAUSING INJURY TO THE OPERATOR DUE TO FALLING COMPONENTS WAS IDENTIFIED AS A POTENTIAL SAFETY RISK. THE INVESTIGATION DETERMINED THAT THE ISSUE INVOLVED A RADIATION SHIELD THAT THE CUSTOMER INDEPENDENTLY SOURCED AND ATTACHED TO THE TABLE RAILS, AND LATER REPLACED THE SCREWS THAT ATTACH THE TABLE TO THE RAILS WITHOUT GE HEALTHCARE INVOLVEMENT. DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER, THE PRODUCT ROOT CAUSE COULD NOT BE ESTABLISHED. NO PROCESS ISSUE WAS IDENTIFIED WITH THE TABLE RAILS, AS THE INSTALLATION REQUIREMENTS ARE OUTLINED IN THE GE HEALTHCARE OPERATOR MANUAL. A GE HEALTHCARE FIELD SERVICE ENGINEER VISITED THE SITE AND CONFIRMED THAT THE SCREWS WERE PROPERLY SECURED, AND THE TABLE RAILS WERE SAFELY TIGHTENED. NO FURTHER ACTION IS PLANNED BY GE HEALTHCARE.