NOT DETERMINED

Additional Manufacturer Narrative

THE SERVICE FSR WAS MOVING A VANGUARD TABLE OUT OF AN MR ROOM WHEN HIS HAND BECAME CAUGHT BETWEEN THE TABLE AND THE MR ROOM DOOR FRAME. USER GUIDES FOR VANGUARD TABLES REFERENCE THAT THERE IS A RISK TO OPERATOR INJURY. THE WARNING STATES ¿KEEP LIMBS AWAY FROM THE GAP BETWEEN THE TABLETOP AND THE SCANNER WHILE RAISING AND LOWERING THE MR PATIENT TABLE.¿ THE SAME PRINCIPLE WOULD APPLY WHEN MOVING THE TABLE, I.E LIMBS SHOULD BE KEPT AWAY FROM THE GAP BETWEEN THE TABLETOP AND OTHER SURFACES. DUE TO THE WEIGHT OF THE TABLE, IT SHOULD BE MANIPULATED SLOWLY TO AVOID IT SWINGING. GE COMMUNICATED THE INCIDENT TO THEIR FIELD ENGINEERS TO BE AWARE OF THE POTENTIAL FOR INJURY IF A BODY PART IS CAUGHT BETWEEN THE TABLE AND MR ROOM DOOR FRAME. THIS IS THE FIRST COMPLAINT FOR THIS TYPE IS FAILURE; THEREFORE, NO DESIGN CHANGE IS WARRANTED AT THIS TIME.

Additional Manufacturer Narrative

THE INVESTIGATION OF THIS EVENT IS ONGOING, FINAL INVESTIGATION RESULTS WILL BE COMMUNICATED AT A LATER DATE.

Description of Event or Problem

A GE HEALTHCARE FSE WAS MOVING A SENTINELLE TABLE WHEN HIS HAND HAD BECOME WEDGED BETWEEN THE TABLE HANDLE AND THE DOOR FRAME. THE DOOR FRAME HAPPEN TO HAVE SHARD EDGES CAUSING AN INCISION IN HIS HAND WHICH REQUIRED STITCHES TO CORRECT.