870 TANDEM NMCT
Received Mar 11, 2025 · Event occurred Jan 29, 2025
Report 9613299-2025-00020 · MDR key 21571061
Device
Generic name
System,tomography,computed,emission
Manufacturer
Ge Medical Systems Israel, Functional ImagingProduct problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
61 YR · Male
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
GEHC INVESTIGATION IS COMPLETE. DURING A SERVICE EVENT AN FE WAS IN PROCESS OF MOVING A COLLIMATOR CART WITHIN THE SCAN ROOM BY USING THE TWO PROVIDED HANDLES. AS THE CART APPROACHED A FLOOR DUCT, THE FE REPOSITIONED HIMSELF TO THE SIDE OF THE CART AND PLACED HIS LEFT HAND ON THE CART HANDLE AND HIS RIGHT HAND ON THE CART STRUCTURE TO MANEUVER IT. DURING THIS ACTION, HIS FINGER GOT CAUGHT/PINCHED BETWEEN THE HANDLE OF THE CART HE WAS MOVING AND HANDLE OF ANOTHER STATIONARY COLLIMATOR CART. AN X-RAY REVEALED A FRACTURE OF HIS LEFT LITTLE (PINKY) FINGER AND THE INJURY WAS TREATED WITH A SPLINT. THE ROOT CAUSE WAS DETERMINED TO BE SERVICE ERROR AS THE FE FAILED TO FOLLOW THE SAFETY PRECAUTIONS IN ACCORDANCE WITH THE SAFETY GUIDE. THERE WAS NO MALFUNCTION OF THE SYSTEM. NO FURTHER ACTIONS PLANNED BY GEHC.
Additional Manufacturer Narrative
LEGAL MANUFACTURER: HCS HAIFA FI - 4 HAYOZMA ST. ISRAEL TIRAT HACARMEL HEFA, 30200. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT A GE HEALTHCARE FIELD ENGINEER SUSTAINED A FINGER FRACTURE DURING SERVICE OF EQUIPMENT WHEN THEIR FINGER WAS CAUGHT BETWEEN THE HANDLES OF THE COLLIMATOR CART HE WAS MOVING AND HANDLES OF ANOTHER STATIONARY COLLIMATOR CART. THERE IS NO INDICATION OF DEVICE MALFUNCTION.