MalfunctionISD
PRIMUS (THE BTE WS30)
Received Feb 18, 2015 · Event occurred Jan 16, 2015
Report 1119903-2015-00001 · MDR key 4531685
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
NO INJURY WAS REPORTED. IN SPECIFIC USE SCENARIOS ONE OF THE PRIMUS TOOLS, THE CHOP LIFT BAR, COULD GET ACCIDENTALLY DISENGAGED FROM THE CONNECTING HOOK THAT MIGHT CAUSE THE CLIENT TO LOSE BALANCE.
Additional Manufacturer Narrative
THERE IS NO NEED TO RETURN THE DEVICE OR THE DEVICE COMPONENTS TO BTE AS THE PROBLEM IS NOT RELATED TO NONCONFORMING PARTS. THE INVESTIGATION IS BEING CONDUCTED USING PARTS FROM INVENTORY. THE PROBLEM CANNOT OCCUR WITH ANY OTHER TOOL OR ATTACHMENT.