InjuryKPY
RADIATION SHIELD SYSTEM
Received Aug 12, 2023
Report MW5134319 · MDR key 17527387
Device
Generic name
Shield, Protective, Personnel
Manufacturer
KenexProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Head Injury
- Laceration(s)
- Head Injury
- Laceration(s)
Narrative
Description of Event or Problem
THIS IS TO INFORM YOU THAT A GE HEALTHCARE FIELD SERVICE ENGINEER HAS BEEN INJURED DURING A SERVICE ACTIVITY ON A 2100-IQ GE SYSTEM. DURING THE REPAIR OF THE VASCULAR TABLE, THE GEHC FIELD SERVICE ENGINEER STOOD UP SUDDENLY AND BUMPED HIS HEAD ON THE RADIATION SHIELD MANUFACTURED BY KEN EX. HE WAS TREATED AT THE HOSPITAL WHERE HE WAS AND HAD 2 STITCHES. IT WAS CONFIRMED THAT THERE WAS NO GE HEALTHCARE SYSTEM INVOLVED THAT CAUSED OR CONTRIBUTED TO THE EVENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).