GE PRECISION MPI
Received May 4, 2020 · Event occurred Mar 11, 2020
Report 1000188474-2020-00001 · MDR key 10021294
Device
Generic name
Image-intensified Fluoroscopic X-ray System
Manufacturer
Nrt X-ray A/sModel number
02980000 (XRF 141)Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AFTER EVALUATION OF ALL THE AVAILABLE INFORMATION, IT IS CONCLUDED THAT THE EVENT HAPPENED DUE TO AN OPERATOR ERROR. THE OPERATOR DROVE THE C-ARM INTO A MOVABLE FLOOR STANDING X-RAY SHIELD (NOT PART OF THE PRECISION MPI DEVICE). THIS CAUSED THE IMAGE INTENSIFIER TO PARTLY BREAK OFF ITS MOUNTING PLATE. NEITHER PATIENT NOR OPERATOR WAS HARMED. THE EVENT COULD HAVE BEEN AVOIDED IF THE OPERATOR HAD FOLLOWED THE WARNINGS AND INSTRUCTIONS IN THE OPERATORS MANUAL AND REMOVED THE FLOOR STANDING X-RAY SHIELD BEFORE MOVING THE C-ARM. THE SYSTEM HAS BEEN REPAIRED ON SITE AND IS IN SERVICE. THE MANUFACTURER EVALUATION IS BASED ON THE EVENT DESCRIPTION AND PHOTOS RECEIVED FROM SITE INCLUDING AN EVALUATION OF HISTORIC COMPLAINT DATA AND TRENDING. WE DO NOT FIND THAT THE DEVICE CONTRIBUTED TO THE EVENT.
Description of Event or Problem
OPERATOR DROVE THE C-ARM INTO A MOVABLE FLOOR STANDING LEAD SHIELD STAND CAUSING THE IMAGE INTENSIFIER (II) TO BECOME LOOSE. THIS DID NOT CAUSE THE II TO FALL BUT RESULTED IN PHYSICAL DAMAGE TO THE EQUIPMENT. PATIENT OR OPERATOR WAS NOT HARMED.