ROTATING IV POLE

Additional Manufacturer Narrative

NO REPORT OF PATIENT INVOLVEMENT. REPORT SOURCE OTHER: (B)(4). THE REPORTED EVENT WAS DUE TO EXCESSIVE TAP DRILL DEPTH RESULTING IN THE THIN WALL SECTION OF THE BLOCK BRACKET ASSEMBLY WHICH IS THE BRACKET THAT ATTACHES THE POLE TO THE BED. A FALL OF THE ROTATING IV POLE COULD RESULT IN AN INJURY TO A BYSTANDER HOLDING THE PATIENT OR TO THE OPERATOR. GE HEALTHCARE INITIATED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 12/08/2017. NO REPORT OF PATIENT INVOLVEMENT. REPORT SOURCE OTHER: (B)(4). THE REPORTED EVENT WAS DUE TO EXCESSIVE TAP DRILL DEPTH RESULTING IN THE THIN WALL SECTION OF THE BLOCK BRACKET ASSEMBLY WHICH IS THE BRACKET THAT ATTACHES THE POLE TO THE BED. A FALL OF THE ROTATING IV POLE COULD RESULT IN AN INJURY TO A BYSTANDER HOLDING THE PATIENT OR TO THE OPERATOR. GE HEALTHCARE INITIATED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 12/08/2017.

Description of Event or Problem

PER MEDWATCH (B)(4): "NURSE REPORTED SHE WAS PUTTING AN OXYGEN FLOW MONITOR ON THE WALL BEHIND AN INFANT WARMER IN THE WELL-BABY NURSERY. SHE MOVED THE OHMED MEDICAL ROTATING IV POLE OUT OF THE WAY (WHICH IS ATTACHED TO THE INFANT WARMER) AND IT ALL SNAPPED OFF AND FELL. NURSE CHECKED THE SCREWS THAT SECURE THE ROTATING IV POLE TO THE WARMER AND THE METAL HOLDING IT TOGETHER HAD BROKEN. THE WEIGHT LIMIT FOR THE POLE IS 9 KG. THE TWO INFUSION DEVICES ON THE ROTATING IV POLE HAD A COMBINED WEIGHT OF 4.21 KG WHICH IS LESS THAN THE WEIGHT LIMIT. IF THERE HAD BEEN A BABY IN THE WARMER IT COULD HAVE SEVERELY INJURED THE BABY. CLINICAL ENGINEERING COMPLETED AN INVESTIGATION OF THIS EVENT AND FOUND THAT THE INTERNAL SLEEVE IN WHICH THE BOLT THAT SECURES CLAMPING PART TO THE POLE WAS SHEARED OFF. NO PATIENT WAS PRESENT DURING THIS EVENT."