VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH

Additional Manufacturer Narrative

A GE HEALTHCARE FIELD ENGINEER (FE) WAS DISPATCHED TO AFFECTED SITE. THE FE REPORTED THAT THE LEFT DRAWER SLIDE HAD PULLED OVER ITS MECHANICAL STOP AND THE RIGHT DRAWER SLIDE WAS BENT AND HAD COMPLETELY BROKEN APART. BOTH SLIDE ASSEMBLIES TO BE REPLACED.

Description of Event or Problem

THIS ADVERSE EVENT WAS REPORTED BY THE GE CLINICAL PRODUCT SURVEILLANCE SPECIALIST ((B)(4)) AS SUCH: "ON THURSDAY THE LEAD TECH PULLED THE SENTINELLE MAMMO TABLE'S LOWER ACCESSORY DRAWER OUT AND IT FELL ON HER FOOT. HER FOOT WAS INJURED BUT DID NOT REQUIRE MEDICAL TREATMENT." GE HEALTHCARE HAS CONTACTED THE SITE 3 ADD'L TIMES TO OBTAIN MORE INFO ON THE EXTENT OF THE FOOT INJURY AND TO SEE IF PT FOLLOW-UP IS REQUIRED. SITE HAS NOT RESPONDED.