PRODIGY

Description of Event or Problem

THERE IS AN ALLEGATION THAT A PT SUSTAINED AN INJURY AFTER A BONE DENSITY EXAM PERFORMED IN (B)(6) 2010. DURING THE EXAM THE SCAN ARM OF THE GE PRODIGY SYSTEM CAME INTO CONTACT WITH ONE OF HER KNEES. ONE MONTH FOLLOWING THE EVENT, THE PT STATED SHE HAD UNDERGONE AN MRI THAT DIAGNOSED HER WITH A MEDIAL MENISCUS TEAR. IT IS NOT KNOWN THE TREATMENT THE PT RECEIVED AS A RESULT OF THIS DIAGNOSIS.

Additional Manufacturer Narrative

SINCE THE INCIDENT OCCURRED MORE THAN TWO YEARS AGO, THE ONLY INFO AVAILABLE IS WHAT WAS PROVIDED BY THE INITIAL REPORTER. THE SYSTEM WAS UNDER GE HEALTHCARE SERVICE CONTACT UNTIL (B)(4) 2010, AND NO ISSUES RELATED TO THIS ISSUE WERE NOTED. THE SYSTEM WAS NOT EVALUATED PROSPECTIVELY BY GE HEALTHCARE SINCE THIS WILL NOT PROVIDE ANY VALUABLE INFO CONSIDERS THE INCIDENT OCCURRED BACK IN 2010. AT THE TIME OF THE INCIDENT THE TECHNOLOGIST ACTIVATED THE EMERGENCY STOP WHEN THE PT ALERTED THAT THE SCAN ARM HAD IMPACTED HER. AFTER THE INCIDENT THE TECH MADE SEVERAL ATTEMPTS TO HAVE PT SEE A PHYSICIAN PRIOR TO LEAVING, BUT SHE REFUSED. THE HOSPITAL TECHNOLOGIST STATED THAT SHE PERFORMED SCANS ON OTHER PTS FOLLOWING THIS INCIDENT; INCLUDING THE SAME DAY, AND HAS NO REOCCURRENCE OF THIS EVENT. THE TECHNOLOGIST ALSO STATED THAT THE SYSTEM DID NOT MALFUNCTION AT THE TIME OF THE INCIDENT, AND THAT PREVENTATIVE MAINTENANCE HAS BEEN PERFORMED ON THE SYSTEM ON A REGULAR BASIS BY A THIRD PARTY SERVICE PROVIDER. AS PER DESIGN, THE UNIT IS EQUIPPED WITH EMERGENCY STOP BUTTONS AND THE MOVEMENT OF SCAN ARM IS LIMITED IN SPEED AND FORCE. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.