6257 XPEDITION HIGH CONFIG

Description of Event or Problem

THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STAIR TREAD/TRACKS DESCENDS/ASCENDS TOO FAST. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT: THE PATIENT EXPERIENCED UNKNOWN.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 4 DEVICES ARE PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Additional Manufacturer Narrative

THE 4 PENDING DEVICES WERE NOT EVALUATED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED THROUGH COMMUNICATION/INTERVIEWS WITH THE USER FACILITY; NO DEFECT OR MALFUNCTION WAS FOUND. SECTION H CODES HAVE BEEN UPDATED.

Description of Event or Problem

THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT. IT WAS ORIGINALLY UNKNOWN, BUT MORE INFORMATION WAS RECEIVED AND THE PATIENT SUSTAINED A BRUISE AND EXPERIENCED PAIN.