inforMED
MalfunctionIXL

DIAGNOST 76

Received Jul 10, 1998 · Event occurred Jun 11, 1998

Report 1217116-1998-00018 · MDR key 176761

Device

Generic name

R/f System (spot Film/image Intensified)

Model number

9870-694-12172

Catalog number

MRF5102

Lot number

NA

Product problems

  • Detachment Of Device Component
  • Component Falling
  • Source, detachment from

Patient

UNKNOWN

  • Head Injury
  • Swelling

Narrative

Description of Event or Problem

REPORTEDLY, WHILE INFANT CHILD WAS BEING X-RAYED, THE COLLIMATOR LAMP COVER ON THE R/F SYSTEM ALLEGED DETACHED FROM THE COLLIMATOR AND STRUCK THE INFANT CHILD IN THE FOREHEAD RESULTING IN A BUMP ON THE CHILD'S FOREHEAD.