INNOVA

Additional Manufacturer Narrative

GE HEALTHCARE HAS COMPLETED THE INVESTIGATION AND CONFIRMED THAT THE DEVICE OPERATED AS DESIGNED. AT THE END OF THE EXAM, THE ANESTHESIOLOGIST STOOD IN A RESTRICTED AREA BETWEEN THE TABLETOP HEAD AND GANTRY DURING PATIENT TRANSFER. THE GANTRY MOTIONS WERE NOT LOCKED AS INSTRUCTED VIA THE USER INTERFACE, AND AN UNAUTHORIZED HOSPITAL STAFF MEMBER ENTERED THE ROOM AND DOUBLE-ENABLED THE JOYSTICK, INITIATING THE MOTION AND RESULTING IN INJURY. THE FIELD ENGINEER INSPECTED THE SYSTEM AND FOUND NO MALFUNCTIONS. AS NO SYSTEM MALFUNCTION WAS IDENTIFIED, NO DEVICE RELATED CORRECTIONS ARE REQUIRED. THE FIELD ENGINEER PROVIDED ADDITIONAL TRAINING ON VASCULAR POSITIONER SAFETY TO THIS CUSTOMER. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE FRANCE BUC YVELINES, 78530. UDI: (B)(4). GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

AT THE END OF AN ANGIOGRAPHY PROCEDURE ON A GE HEALTHCARE SYSTEM, UNINTENDED ACTIVATION OF THE VASCULAR NAVIGATION JOYSTICK CAUSED THE PIVOT AXIS MOTOR TO MOVE. AN ANESTHESIA CLINICIAN POSITIONED NEAR THE GANTRY, SUPPORTING THE PATIENT'S HEAD, BECAME TRAPPED BY THE GANTRY'S PIVOT MOVEMENT, RESULTING IN A LEG FRACTURE.