PRIMUS, BTE WS30
Received Apr 19, 2013 · Event occurred Mar 21, 2013
Report 1119903-2013-00002 · MDR key 3074880
Device
Manufacturer
Bte Technologies, Inc.Model number
PRIMUSRSProduct problems
- Unintended Movement
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE OPERATOR WAS PERFORMING A CONTINUOUS PASSIVE MOTION (CPM) TEST ON A PT'S WRIST. THE PT'S HAND WAS STRAPPED TO THE SYS ATTACHMENT (TOOL) WITH VELCRO IN ACCORDANCE WITH THE OPERATING INSTRUCTIONS. ON ONE OF THE REPETITIONS THE PRIMUS TRAVELLED PAST THE DESIRED RANGE OF MOTION BENDING THE PT'S WRIST UPWARD. AT THIS TIME A MESSAGE WAS DISPLAYED INDICATING A COMMUNICATION ISSUE WITH THE PRIMUS. THE PT WAS ABLE TO UNDO THE STRAPS AND PULL THEIR ARMS OUT OF THE ARM REST. THE CLINICIAN THEN UNPLUGGED THE MACHINE. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
AS PER NORMAL BTE SVC PROCESS, REPLACEMENT PARTS WERE PROVIDED TO THE CLINIC. HOWEVER, PARTS FROM THE CUSTOMER SITE HAVE NOT BEEN RETURNED YET TO BTE. IT HAS BEEN VERIFIED THAT THE PARTS ARE IN TRANSIT. THE PT DATA WILL BE AVAILABLE ONCE PARTS FROM THE CUSTOMER SITE ARE REC'D AT BTE. THE PT IS AN ADULT.