inforMED
MalfunctionIZJ

INTEGRIS CATH LAB SYSTEM

Received May 14, 1996 · Event occurred May 11, 1996

Report MW1009098 · MDR key 33000

Device

Generic name

Cath Lab System

Product problems

  • Break
  • Component(s), broken
  • False Device Output

Patient

NO INFO

  • Radiation Overdose

Narrative

Description of Event or Problem

A SVC TECH WAS REPAIRING THE CATH LAB SYSTEM. IT WAS REPORTED TO SVC THAT FLUORO WAS "STAYING ON." WHILE TECH WAS CHECKING THE FLUORO FOOT SWITCH (SYSTEM NOT ON AT THIS TIME), A NURSE CAME INTO THE ROOM AND PLACED A CINE FILM CANISTER NOT THE CINE CAMERA. THIS CAUSED THE SYSTEM TO IMMEDIATELY PRODUCE CINE X-RAY. BOTH THE TECH AND NURSE WERE TEMPORARILY EXPOSED AS NEITHER WERE WEARING LEAD. THE TECH PUT ON LEAD AND WENT BACK INTO THE ROOM TO FIND THAT THE CINE FOOT SWITCH WAS THE CAUSE OF THE PROBLEM, NOT FLUORO. FAILURE MODE IS SUCH THAT THE PLASTIC ACTUATORS IN FOOT SWITCH BROKE OFF AND CAUSED THE ACTIVATION. THIS HAS OCCURRED ON MORE THAN ONE OCCASION.