inforMED
MalfunctionIZW

ULTRANET S

Received May 30, 2007 · Event occurred Apr 15, 2007

Report 9611343-2007-00043 · MDR key 857438

Device

Model number

2204643

Catalog number

NA

Lot number

NA

Product problems

  • Detachment Of Device Component
  • Component Falling

Patient

YR

  • Injury

Narrative

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE EVENT WAS THREE OF THE SIX SCREWS USED TO HOLD THE COLLIMATOR WERE MISSING. THERE IS DOCUMENTATION IN THE SERVICE MANUAL INSTRUCTING THE PERIODIC CHECKING OF THE FASTENERS HOLDING THE COLLIMATOR. ATTEMPTS WERE MADE TO GET THE PATIENT INFORMATION, THEY WERE UNSUCCESSFUL.

Description of Event or Problem

IT WAS REPORTED THAT THE COLLIMATOR FELL FROM THE X-RAY ASSEMBLY AND WAS CAUGHT BY THE XR TECHNOLOGIST WHO REPORTED A SPRAINED HAND. THE CONCERN IS THAT IF THE EVENT WERE TO RECUR, SERIOUS INJURY MAY RESULT.