6257 XPEDITION POWERED CHAIR

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE GOT STUCK ON THE WAY UP A SLIGHTLY WINDING STAIRCASE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Additional Manufacturer Narrative

AFTER INVESTIGATION, IT WAS DETERMINED THAT THE ISSUE OCCURRED DURING A DEMONSTRATION OF THE CHAIR. THE USER WAS TOO CLOSE TO THE RAILING ON A WINDING STAIRCASE, AND THE TRACKS CAUGHT PART OF THE RAILING. A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY A STRYKER FIELD SERVICE TECHNICIAN. IT WAS FOUND THAT THE DIFFICULT TO MANEUVER CHAIR WAS DUE TO USER ERROR, RESULTING IN A BENT TRACK RAIL GUIDE CAGE. THIS ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE TRACK GUIDE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE GOT STUCK ON THE WAY UP A SLIGHTLY WINDING STAIRCASE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.