inforMED
MalfunctionIZZ

COMPAX 40E

Received Dec 16, 2014 · Event occurred Nov 17, 2014

Report 2126677-2014-00025 · MDR key 4350569

Device

Model number

XRA003

Product problems

  • Detachment of Device or Device Component

Patient

Not reported

  • No Code Available

Narrative

Additional Manufacturer Narrative

GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE TECHNOLOGIST WAS REPOSITIONING THE TUBE OF A COMPAX 40E X-RAY SYSTEM AFTER DOING AN AP UPRIGHT VIEW, THE COLLIMATOR DETACHED AND HIT HER ON THE WRIST. A PT WAS ON THE TABLE AT THE TIME BUT WAS NOT INJURED. THERE WAS NO INJURY TO THE TECHNOLOGIST AS A RESULT OF THE COLLIMATOR IMPACTING THE WRIST.