WALKAWAY-40 SI

Additional Manufacturer Narrative

BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT DURING SERVICE VISIT. FSE FOUND THAT THE HATCH DOOR GAS SHOCK WAS NOT HOLDING THE HATCH UP. FSE REPLACED THE WORN OUT DOOR SPRING PART NUMBER 5601-0070. AFTER REPLACING THE FAULTY SPRING, THE SERVICE HATCH DOOR FUNCTIONED AS EXPECTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE SERVICE HATCH DOOR ON THE WALKAWAY (WA) 40SI HIT AN OPERATOR ON THE HEAD. IT WAS SUSPECTED THAT THE DOOR MAY NOT HAVE BEEN OPENED FULLY CAUSING IT TO DROP SLOWLY UNTIL IT HIT THE HEAD OF THE OPERATOR HOWEVER MEDICAL ATTENTION WAS NOT REQUIRED. THE OPERATOR PUSHED THE DOOR ALL THE WAY UP AND IT SEEMED TO BE HOLDING IN THAT POSITION BUT STILL HAD REQUESTED SERVICE TO CHECK IT OUT. IT WAS ALSO REPORTED THAT THE SAME ISSUE HAD OCCURRED ONCE BEFORE AND THAT THE TECHNICIAN DID NOT REQUIRE MEDICAL ATTENTION. NO REPORT OF SERIOUS INJURY AND NO ADDITIONAL DETAILS WERE PROVIDED REGARDING THE PREVIOUS INCIDENT. THE CUSTOMER DID NOT PREVIOUSLY REPORT THE EVENT TO BECKMAN COULTER. THERE WAS NO SERIOUS INJURY REPORTED IN CONNECTION WITH THIS EVENT.

Additional Manufacturer Narrative

THERE WAS NO UNIQUE DEVICE IDENTIFIER LABELING WHEN THE AFFECTED INSTRUMENT WAS MANUFACTURED AND INSTALLED. THE INSTRUMENT IS A CLASS II DEVICE THAT WAS MANUFACTURED ON 11/01/2005 PRIOR TO THE FDA'S MANDATED DEADLINE OF 09/24/2016. BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS CF170228-146.