INNOVA 4100
Received Apr 14, 2025 · Event occurred Jan 28, 2025
Report 9611343-2025-00006 · MDR key 21832426
Device
Generic name
Interventional Fluoroscopic X-ray
Manufacturer
Ge Medical Systems ScsProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR · Male
- Radiation Burn
- Radiation Burn
Narrative
Description of Event or Problem
ON MARCH 21, 2025, A GE HEALTHCARE (GEHC) TECHNICAL SUPPORT ENGINEER WAS INFORMED BY A CUSTOMER THAT A PATIENT SUSTAINED A RADIATION INJURY TO THE SKIN FOLLOWING A LENGTHY PROCEDURE WITH A GE HEALTHCARE INNOVA 4100 SYSTEM ON (B)(6), 2025. AN INVESTIGATION IS IN PROGRESS.
Additional Manufacturer Narrative
LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE FRANCE BUC YVELINES, 78530. THE GE HEALTHCARE DEVICE HAS NO UDI SINCE IT WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.
Additional Manufacturer Narrative
GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. A REVIEW OF THE SYSTEM LOGS CONFIRMED THAT THE SYSTEM OPERATED WITHIN ITS SPECIFICATIONS. THE ADDITIONAL X-RAY DOSE WAS ATTRIBUTED TO THE OPERATOR DECISION. THE PATIENTÂS INJURY WAS DETERMINED TO BE AN ISOLATED CASE, RESULTING FROM A COMPLEX AND PROLONGED FLUOROSCOPIC PROCEDURE. FOR LARGER PATIENTS, SUCH PROCEDURES MAY LEAD TO SKIN INJURIES WHICH IS A KNOWN SIDE EFFECT. IT IS THE PHYSICIAN'S RESPONSIBILITY TO ASSESS THE BENEFITS VERSUS THE POTENTIAL RISKS FOR EACH PATIENT. THE INVESTIGATION IS NOW CLOSED, AND NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.