inforMED
MalfunctionIWY

TOSHIBA CT SYSTEM ACCESSORIES, CARBON FIBER

Received May 9, 2013 · Event occurred Apr 25, 2013

Report 3110505 · MDR key 3110505

Device

Generic name

Holder, Head, Radiographic

Model number

*

Catalog number

9091

Lot number

*

Product problems

  • Break
  • Detachment Of Device Component
  • Component Falling

Patient

*

  • Injury

Narrative

Description of Event or Problem

CT TECHNOLOGIST WAS CHANGING THE HEAD HOLDER ON A CT MACHINE. THE HEAD HOLDER IS MADE OF CARBON FIBER. A PIECE OF THE CARBON FIBER SPLINTERED OFF INTO THE PALM OF THE TECHNOLOGIST'S HAND. THE SPLINTER WAS REMOVED, THE TECHNOLOGIST'S HAND WAS CLEANED AND SHE WENT TO EMPLOYEE HEALTH. NO ADVERSE EFFECTS FROM THE INJURY. THE HEAD HOLDER DID NOT HAVE ANY DIRECT PATIENT CONTACT, IN THIS CASE, BUT THERE IS A POTENTIAL FOR A CARBON FIBER TO SPLINTER OFF AND INJURE A PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THE CT HEAD HOLDER WAS BEING CLEANED AT THE TIME AND NOT ACTIVELY BEING USED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.