6257 XPEDITION POWERED CHAIR

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 6 DEVICES ARE PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULT TO MANEUVER UNIT WHICH DOES NOT RESULT IN A TIP. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DEVICES THAT WERE PENDING EVALUATION WERE NOT MADE AVAILABLE BY THE CUSTOMER; THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS): 2 DEVICES: APPROPRIATE TERM/CODE NOT AVAILABLE/NO FINDINGS AVAILABLE.

Description of Event or Problem

NO NEW INFORMATION.