inforMED
OtherIWQ

PHILLIPS SIEMENS

Received Sep 13, 2000 · Event occurred Aug 14, 2000

Report 296360 · MDR key 296360

Device

Generic name

Lead Glass Shiled On Arm

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Component(s), broken
  • Component Falling
  • Solder Joint Fracture

Patient

70 YR

  • Fracture, Arm

Narrative

Description of Event or Problem

LEAD SHIELD (GLASS) SEPARATED FROM ARM AND FELL. GRAZED PT - NO SKIN TEAR OR BRUISING. POSSIBLE FRACTURE TO PHYSICIAN'S ARM. MINIMUM WELDING NOTED AT SAME SITE ON OTHER ARM. OCCURRED IN CATH LAB. THE SHIELD SEPARATED FROM THE DEVICE AND FELL ON A PHYSICIAN'S ARM, CAUSING A HAIRLINE FRACTURE. IT GRAZED THE PT, BUT CAUSED NO INJURY TO THE PT. CATH LAB PERSONNEL NOTIFIED THE CO IMMEDIATELY, AND HOSP MAINTENANCE DEPT MADE THE NECESSARY REPAIR. THE INCIDENT OCCURRED 8/14/00, HOWEVER RISK MGMT WAS NOT MADE AWARE UNTIL 9/8/00, AT WHICH TIME A REPORT WAS COMPLETED.