DISCOVERY XR656
Received Jun 26, 2015 · Event occurred May 29, 2015
Report 9613445-2015-00005 · MDR key 4871752
Device
Generic name
System, X-ray, Tomographic
Manufacturer
Ge Hangwei Medical Systems Co., Ltd.Product problems
- Loose or Intermittent Connection
- Device Operates Differently Than Expected
Patient
25 YR
- Bone Fracture(s)
- Laceration(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING INSTALLATION OF THE DISCOVERY XR656 WALL STAND, IT WAS IDENTIFIED THAT THE COUNTERWEIGHTS WITHIN THE WALL STAND COLUMN WERE NOT MOVING UP AND DOWN AS THE DETECTOR ARM WAS MOVED. AT THAT TIME, THE VENDOR FIELD ENGINEER (FE) REMOVED THE WALL STAND TOP COVER TO CHECK THE COUNTERWEIGHTS AND IDENTIFIED THE BELT THAT IS RESPONSIBLE FOR LIFTING THE COUNTERWEIGHTS WAS LOOSE. AS THE FE WAS TROUBLESHOOTING THIS EVENT, THE FE PUT THEIR HAND UNDER THE SUSPENDED COUNTERWEIGHTS WHEN THE COUNTERWEIGHTS SUDDENLY FELL AND IMPACTED THE FIELD ENGINEER'S FINGER. THE FIELD ENGINEER RECEIVED A FRACTURE AND LACERATION ON THEIR LEFT RING FINGER. THE TREATMENT THAT WAS COMPLETED WAS TO CLEAN AND SUTURE THE WOUND.
Additional Manufacturer Narrative
THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative
GE HEALTHCARE'S INVESTIGATION HAS CONCLUDED AND THE CAUSE OF THIS EVENT WAS DETERMINED TO BE AN INSTALLATION ERROR AS THE INSTALLER SHOULD NEVER POSITION THEIR HANDS DIRECTLY UNDER THE COUNTERWEIGHTS DURING SERVICING OR INSTALLATION OF THIS DEVICE.